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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2051210110 | Registry Identifier | jRCT |
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The main aim of the study is to check for side effects from TAK-771, and to check how well TAK-771 controls symptoms in Japanese participants with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN)
The participants will be treated with TAK-771 for 45 months as a maximum.
There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug (every 2, 3, or 4 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: TAK-771 for CIDP Participants | Experimental | TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks. |
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| Cohort 2: TAK-771 for MMN Participants | Experimental | TAK-771 includes IGI 10% and rHuPH20. Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 2, 3, or 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-771 | Drug | Intervention description; Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Epoch 1: Percentage of Participants With CIDP Who Experienced Relapse | Relapse was defined as worsening of functional disability defined as an increase of >=1 point relative to the pre-subcutaneous (pre-SC) treatment baseline score in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability scale was the most widely used assessment tool to measure the functional activity level of participants with CIDP. The INCAT disability scale consisted of upper and lower extremity components, with a maximum of 5 points for the upper extremities (arm disability) and a maximum of 5 points for the lower extremities (leg disability), which were summed for an overall INCAT disability score ranging from 0 to 10 points, where 0 was normal and 10 was severely incapacitated. An adjusted INCAT disability score was the same as the INCAT disability score, with the only exception in the exclusion of changes from 0 (normal) to 1 (minor symptoms) (or vice versa) in upper limb function. | Epoch 1: Baseline up to 6 months |
| Epoch 1: Change From Baseline in Maximum Grip Strength in the More Affected Hand in Participants With MMN | The Martin Vigorimeter was used to assess grip strength in both hands. The instrument consisted of a compressible rubber ball that was connected to a manometer. When the rubber ball was squeezed, the force of compression was measured in kilopascal (kPa) ranging from 0 to 160 kPa. | Epoch 1: Baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as adverse events that occurred during or after administration of the first dose of investigational product (IP). TEAEs caused in Epoch 1 were defined as AEs that occurred on or after the start of study drug administration, and before the first dose of IP in Epoch 2 (6 months). TEAEs caused in Epoch 2 (6 months) were defined as AEs that began during or after administration of the first dose of IP in Epoch 2 (6 months). |
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Inclusion criteria
Be a Japanese person.
The participant is male or female >=18 years old at the time of screening.
Participant has a documented diagnosis of definite or probable CIDP (focal atypical CIDP and pure sensory atypical CIDP will be excluded) or definite or probable MMN, as confirmed by a neurologist specializing/experienced in neuromuscular diseases to be consistent with the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2010 criteria.
Participant has responded to IgG treatment in the past (partial or complete resolution of neurological symptoms and deficits), and must currently be on stable doses of IVIG treatment within the dose range equivalent to a cumulative monthly dose of 0.4 to 2.4 g/kg BW (inclusive) administered intravenously for at least 12 weeks prior to screening. The dosing interval of intravenous immunoglobulin (IVIG) treatment must be between 2 and 6 weeks (inclusive). Variations in the dosing interval of up to ±7 days or monthly dose amount of up to +or-20% between participant's pre-study IgG infusions are within acceptable limits.
CIDP participants only - INCAT disability score between 0 and 7 (inclusive). Participants with INCAT scores of 0, 1 (whether from upper or lower extremities), or 2 (if at least 1 point is from an upper extremity) at screening and/or baseline will be required to have a history of significant disability as defined by an INCAT disability score of 2 (must be exclusively from the lower extremities) or greater documented in the medical record. Participants will be eligible if one of the below eligibility criteria are met:
If female of childbearing potential, the participant must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the study and for at least 30 days after the last administration of IP.
The participant is willing and able to sign an Informed Consent Form (ICF).
The participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria CIDP patients
Participants with focal atypical CIDP or pure sensory atypical CIDP or multifocal acquired demyelinating sensory and motor neuropathy (MADASAM).
Participants with any neuropathy of other causes, including:
Participant with other neuropathies (eg, diabetic, lead, porphyric or vasculitic neuropathy, chronic inflammatory demyelinating polyradiculoneuropathy, Lyme neuroborreliosis, post radiation neuropathy, hereditary neuropathy with liability to pressure palsies, CMT neuropathies, meningeal carcinomatosis).
CIDP/MMN Patients
Participant with immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein.
Participant with presence of prominent sphincter disturbance.
Participant with any central demyelinating disorders such as multiple sclerosis.
Participant with any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of endpoint measures, including (but not limited to) arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy.
(Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy and who have adequate glycemic control with hemoglobin A1c [HbA1c] level of <7.5% at screening will be eligible for the study, provided the electrodiagnostic criteria are consistent with the diagnosis of a definite or probable CIDP consistent with the EFNS/PNS 2010 criteria and the participant agrees to maintain adequate glycemic control.)
Participant with congestive heart failure (New York Heart Association [NYHA] class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (defined as diastolic blood pressure >100 mmHg and/or systolic blood pressure >160 mmHg).
Participant with a history of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) within 12 months prior to screening.
Participant with condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome).
Participant with a known history of chronic kidney disease, or glomerular filtration rate of <60 mL/min/1.73m^2 estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the time of screening.
Participant with active malignancy requiring chemotherapy and/or radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions to this exclusion are: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment.
Participant with clinically significant anemia that precludes repeated blood sampling during the study, or hemoglobin (Hgb) level of <10.0 g/dL at the time of screening.
Participant with a known history of hypersensitivity or ARs such as urticaria, breathing difficulty, severe hypotension, or anaphylaxis following administration of human blood products such as human IgG, albumin, or other blood components.
(Clinically non-significant skin reactions, as per the investigator's and the sponsor medical monitor's discretion, do not meet this exclusion criterion. Clinically non-significant skin reactions may include local reactions to injection such as injection site's itching, redness, erythema, or swelling.)
Participant has a known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin such as bee or wasp venom.
Participant with immunoglobulin A (IgA) deficiency and antibodies against IgA and a history of hypersensitivity.
Participant with an abnormal laboratory values at screening meeting any one of the following criteria:
Participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAG), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2.
Participant has received or is currently receiving treatment with immunomodulatory/immunosuppressive agents within 6 months prior to screening.
Participant has received or is currently receiving treatment with any corticosteroids dose within 8 weeks prior to screening, regardless of indication.
Participant has undergone PE within 3 months prior to screening.
Participant has any disorder or condition that in the investigator's judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study.
Participant is nursing or intends to begin nursing during the course of the study.
Participant has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
Participant is a family member or employee of the investigator.
Participants with known acquired or inherited thrombophilic disorders. These will include the specific types of acquired or inherited thrombophilic disorders that could put participants at risk of developing thrombotic events. Examples include a. Hereditary thrombophilia: i. Factor V Leiden mutation. ii. Prothrombin 20210A mutation. iii. Protein C deficiency. iv. Protein S deficiency. v. Anti-thrombin deficiency. b. Acquired thrombophilia: i. Anti-phospholipid antibody syndrome. ii. Activated protein C Resistance acquired. iii. Homocystinemia.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University Hospital | Nagakute | Aichi-ken | Japan | |||
| Chubu Rosai Hospital |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
The results are presented up to Epoch 2 (6 months), based on the second interim analysis cutoff date (August 20, 2024). The study is ongoing, and participants who have tolerated the treatment well and voluntarily wish to continue TAK-771 administration may remain in Epoch 2 (continued) until the commercial availability of TAK-771. Additional results will be provided upon study completion date.
Participants took part in the study at 23 investigative sites in Japan. A total of 26 participants were enrolled and treated in this study, which consisted of two treatment epochs (Epoch 1 and Epoch 2) with two cohorts: chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in Cohort 1 and multifocal motor neuropathy (MMN) in Cohort 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epoch 1, Cohort 1 (CIDP): TAK-771 | TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Epoch 1: Up to 6 Months |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2024 | Feb 24, 2025 |
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| Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Participants With Serious Adverse Events (SAEs) | SAEs were defined as any untoward clinical manifestation of signs, symptoms, outcomes (related to IP or not) at any dose: resulted in death, was life-threatening, required inpatient/prolongation of hospitalization, resulted in persistent/significant disability/incapacity, congenital abnormality/birth defect, or any other important medical event. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs | Related SAES and TEAEs: that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which possible involvement of the drug cannot be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant medications and concurrent treatments, may also be responsible. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious Adverse Reactions (ARs) Plus Suspected ARs | Adverse reactions plus suspected ARs were defined as TEAEs that were considered by the investigator to be related to IP administration, or for which the causality was indeterminate or missing, or that began during infusion of IP or within 72 hours following the end of IP infusion. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Participants With SAEs and/or TEAEs Associated With Infusions | Infusion associated SAEs and/or TEAEs were defined as SAEs and/or TEAEs considered to be "infusion-related reactions" by investigators. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs Associated With Infusions | Related SAES and TEAEs: that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which possible involvement of the drug cannot be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant medications and concurrent treatments, may also be responsible. SAEs and TEAEs associated with infusions were the events considered to be "infusion-related reactions" by investigators. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Participants With TEAEs Temporally Associated With Infusions | TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP. TEAEs caused in Epoch 1 were defined as AEs that occurred on or after the start of study drug administration, and before the first dose of IP in Epoch 2 (6 months). TEAEs caused in Epoch 2 (6 months) were defined as AEs that began during or after administration of the first dose of IP in Epoch 2 (6 months). TEAEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious ARs Plus Suspected ARs Temporally Associated With Infusions | Adverse reactions plus suspected ARs were defined as TEAEs that were considered by the investigator to be related to IP administration, or for which the causality was indeterminate or missing, or that began during infusion of IP or within 72 hours following the end of IP infusion. AEs temporally associated with infusions are defined as AEs occurring during or within 72 hours after completion of an infusion. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Participants With Systemic TEAEs Associated With Infusions | Any TEAEs other than local TEAEs were considered a systemic TEAE. Infusion associated TEAEs were defined as TEAE considered to be "infusion-related reactions" by investigators. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Local Infusion Site Reactions Associated With Infusions | Any reaction with the medical dictionary for regulatory activities (MedDRA) high-level group term (HLGT) of "Administration site reactions" were considered a local infusion site reaction (local TEAE). In addition, any TEAE with Injection Site Reaction Flag = "Yes" was considered a local TEAE. Infusion associated reaction were defined as event considered to be "infusion-related reactions" by investigators. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or AEs | Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs were reported. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1 and 2 (6 Months): Number of Participants With Positive Binding Antibodies, and Positive Neutralizing Antibodies to rHuPH20 | Plasma samples for the detection of anti-rHuPH20 binding and neutralizing antibodies were collected. Participants were monitored for the formation of anti-rHuPH20 antibodies using validated anti-rHuPH20 antibody detection assay (also known as the Screening and Confirmatory Binding Assay). Positive antibodies were defined as participants who had anti rHuPH20 antibody titer greater than or equal to (>=) 1:160 at least one time during treatment. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1: Percentage of Participants With Clinical Worsening of CIDP | Clinical Worsening of CIDP was defined as a >=8 kPa decrease in hand grip strength in the more affected hand OR >=4 points decrease in Rasch Built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score at 2 consecutive time points. Hand grip strength was measured using the Martin vigorimeter by quantifying air pressure. The R-ODS was a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. R-ODS was comprised of 24 items that rate participant's functioning related to a variety of everyday tasks at moment of completion on a scale of 0 to 2 (where 0 indicates it is not possible for the respondent to perform the task and 2 means that task can be performed without difficulty). Total scores range from 0 to 48 and higher scores indicate greater ability to perform daily and social tasks. | Epoch 1: Baseline until end of Epoch 1 or relapse (up to 6 months) |
| Epoch 1 and 2 (6 Months): Time to Relapse in Participants With CIDP | Time to relapse was defined as time from the date of the first SC administration of TAK-771 in Epoch 1 or 2 to the date of relapse. | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| Epoch 1: Change From Pre-subcutaneous Treatment (Baseline) in R-ODS Total Score in Participants With CIDP | The R-ODS was a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. R-ODS was comprised of 24 items that rate participant's functioning related to a variety of everyday tasks at moment of completion on a scale of 0 to 2 (where 0 indicates it is not possible for the respondent to perform the task and 2 means that task can be performed without difficulty). Total scores range from 0 to 48 and higher scores indicate greater ability to perform daily and social tasks. | Epoch 1: Baseline up to 6 months |
| Epoch 1: Change From Pre-subcutaneous Treatment (Baseline) in an Average of Handgrip Strength of Both Hands in Participants With CIDP and MMN | The Martin Vigorimeter was used to assess grip strength in both hands. The instrument consisted of a compressible rubber ball that was connected to a manometer. When the rubber ball was squeezed, the force of compression was measured in kPa ranging from 0 to 160 kPa. Average of grip strength was defined as an average of the two maximum values: maximum of the 3 measurements in the more affected hand and the maximum of the 3 measurements in the less affected hand. | Epoch 1: Baseline up to 6 months |
| Epoch 1: Change From Pre-subcutaneous Treatment (Baseline) Total Medical Research Council (MRC) Sum Score in Participants With MMN | The MRC sum score served as a measure of muscle strength. The following muscles on each side of the body were examined and the strength of each muscle was rated according to the MRC scale: deltoids, biceps, wrist extensors, iliopsoas, quadriceps, and anterior tibialis. The MRC scale ranged from 0 to 5, where: 0 = no visible contraction; 1 = visible contraction without movement of the limb; 2 = movement of the limb but not against gravity; 3 = movement against gravity over (almost) the full range; 4 = movement against gravity and resistance; and 5 = normal. All scores from both left and right side of the body were summed to obtain the total MRC sum score. The total MRC sum score ranged from 0 (paralysis) to 60 (normal strength) with higher score indication normal strength. | Epoch 1: Baseline up to 6 months |
| Epoch 1: Number of MMN Participants With Increased Guy's Neurological Disability Scale (GNDS) Score in Upper Limb and Lower Limb Categories | GNDS was a questionnaire which consisted of 12 separate categories (4 to 8 questions per category). The categories included: cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and others. In the current study, only 2 categories; upper limb function and the lower limb function was used for assessment of the disability of participants with MMN. The severity of each subscale (including upper limb and lower limb) was graded from 0 (normal function) to 5 (total loss of function) based according to severity and impact on the individual. The total GNDS score was the sum of the 12 separate scores ranging between 0 and 60 with higher scores indicating loss of function. | Epoch 1: Baseline up to 6 months |
| Nagoya |
| Aichi-ken |
| Japan |
| Fujita Health University Hospital | Toyoake | Aichi-ken | Japan |
| Asahikawa Medical Center | Asahikawa | Hokkaido | Japan |
| Kansai Rosai Hospital | Amagasaki | Hyōgo | Japan |
| Hyogo College of Medicine Hospital | Nishinomiya | Hyōgo | Japan |
| St.Marianna University School of Medicine Hospital | Kawasaki | Kanagawa | Japan |
| Tohoku Medical and Pharmaceutical University Hospital | Sendai | Miyagi | Japan |
| Nara Medical University Hospital | Kashihara | Nara | Japan |
| Shiga University of Medical Science Hospital | Ōtsu | Shiga | Japan |
| Tokushima National Hospital | Yoshinogawa | Tokushima | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | Japan |
| National Center of Neurology and Psychiatry | Kodaira | Tokyo | Japan |
| Toho University Omori Medical Center | Ōta-ku | Tokyo | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo | Japan |
| Yamaguchi University Hospital | Ube | Yamaguchi | Japan |
| Chiba University Hospital | Chiba | Japan |
| Kyushu University Hospital | Fukuoka | Japan |
| Hiroshima University Hospital | Hiroshima | Japan |
| Kumamoto University Hospital | Kumamoto | Japan |
| Higashimatsuyama Municipal Hospital | Saitama | Japan |
| Tokushima University Hospital | Tokushima | Japan |
| Toyama University Hospital | Toyama | Japan |
| FG001 | Epoch 1, Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1. |
| FG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| FG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Epoch 2: Up to 6 Months |
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Full Analysis Set (FAS) included all enrolled participants who received TAK-771 at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | Epoch 1, Cohort 1 (CIDP): TAK-771 | TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse. |
| BG001 | Epoch 1, Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Epoch 1: Percentage of Participants With CIDP Who Experienced Relapse | Relapse was defined as worsening of functional disability defined as an increase of >=1 point relative to the pre-subcutaneous (pre-SC) treatment baseline score in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability scale was the most widely used assessment tool to measure the functional activity level of participants with CIDP. The INCAT disability scale consisted of upper and lower extremity components, with a maximum of 5 points for the upper extremities (arm disability) and a maximum of 5 points for the lower extremities (leg disability), which were summed for an overall INCAT disability score ranging from 0 to 10 points, where 0 was normal and 10 was severely incapacitated. An adjusted INCAT disability score was the same as the INCAT disability score, with the only exception in the exclusion of changes from 0 (normal) to 1 (minor symptoms) (or vice versa) in upper limb function. | FAS included all enrolled participants who received TAK-771 at least once. | Posted | Number | 95% Confidence Interval | percentage of participants | Epoch 1: Baseline up to 6 months |
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| Primary | Epoch 1: Change From Baseline in Maximum Grip Strength in the More Affected Hand in Participants With MMN | The Martin Vigorimeter was used to assess grip strength in both hands. The instrument consisted of a compressible rubber ball that was connected to a manometer. When the rubber ball was squeezed, the force of compression was measured in kilopascal (kPa) ranging from 0 to 160 kPa. | FAS included all enrolled participants who received TAK-771 at least once. | Posted | Mean | Standard Deviation | kPa | Epoch 1: Baseline up to 6 months |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as adverse events that occurred during or after administration of the first dose of investigational product (IP). TEAEs caused in Epoch 1 were defined as AEs that occurred on or after the start of study drug administration, and before the first dose of IP in Epoch 2 (6 months). TEAEs caused in Epoch 2 (6 months) were defined as AEs that began during or after administration of the first dose of IP in Epoch 2 (6 months). | Safety analysis set (SAS)included all enrolled participants who received TAK-771 administration at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Serious Adverse Events (SAEs) | SAEs were defined as any untoward clinical manifestation of signs, symptoms, outcomes (related to IP or not) at any dose: resulted in death, was life-threatening, required inpatient/prolongation of hospitalization, resulted in persistent/significant disability/incapacity, congenital abnormality/birth defect, or any other important medical event. | SAS included all enrolled participants who received TAK-771 administration at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs | Related SAES and TEAEs: that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which possible involvement of the drug cannot be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant medications and concurrent treatments, may also be responsible. | SAS included all enrolled participants who received TAK-771 administration at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious Adverse Reactions (ARs) Plus Suspected ARs | Adverse reactions plus suspected ARs were defined as TEAEs that were considered by the investigator to be related to IP administration, or for which the causality was indeterminate or missing, or that began during infusion of IP or within 72 hours following the end of IP infusion. | SAS included all enrolled participants who received TAK-771 administration at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With SAEs and/or TEAEs Associated With Infusions | Infusion associated SAEs and/or TEAEs were defined as SAEs and/or TEAEs considered to be "infusion-related reactions" by investigators. | SAS included all enrolled participants who received TAK-771 administration at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs Associated With Infusions | Related SAES and TEAEs: that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which possible involvement of the drug cannot be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant medications and concurrent treatments, may also be responsible. SAEs and TEAEs associated with infusions were the events considered to be "infusion-related reactions" by investigators. | SAS included all enrolled participants who received TAK-771 administration at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
| ||||||||||||||||||||||||||||
| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With TEAEs Temporally Associated With Infusions | TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP. TEAEs caused in Epoch 1 were defined as AEs that occurred on or after the start of study drug administration, and before the first dose of IP in Epoch 2 (6 months). TEAEs caused in Epoch 2 (6 months) were defined as AEs that began during or after administration of the first dose of IP in Epoch 2 (6 months). TEAEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion. | SAS included all enrolled participants who received TAK-771 administration at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious ARs Plus Suspected ARs Temporally Associated With Infusions | Adverse reactions plus suspected ARs were defined as TEAEs that were considered by the investigator to be related to IP administration, or for which the causality was indeterminate or missing, or that began during infusion of IP or within 72 hours following the end of IP infusion. AEs temporally associated with infusions are defined as AEs occurring during or within 72 hours after completion of an infusion. | SAS included all enrolled participants who received TAK-771 administration at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Systemic TEAEs Associated With Infusions | Any TEAEs other than local TEAEs were considered a systemic TEAE. Infusion associated TEAEs were defined as TEAE considered to be "infusion-related reactions" by investigators. | SAS included all enrolled participants who received TAK-771 administration at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Local Infusion Site Reactions Associated With Infusions | Any reaction with the medical dictionary for regulatory activities (MedDRA) high-level group term (HLGT) of "Administration site reactions" were considered a local infusion site reaction (local TEAE). In addition, any TEAE with Injection Site Reaction Flag = "Yes" was considered a local TEAE. Infusion associated reaction were defined as event considered to be "infusion-related reactions" by investigators. | SAS included all enrolled participants who received TAK-771 administration at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or AEs | Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs were reported. | SAS included all enrolled participants who received TAK-771 administration at least once. | Posted | Number | infusions | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 | Total Number of Infusions Administered | Total Number of Infusions Administered |
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| Secondary | Epoch 1 and 2 (6 Months): Number of Participants With Positive Binding Antibodies, and Positive Neutralizing Antibodies to rHuPH20 | Plasma samples for the detection of anti-rHuPH20 binding and neutralizing antibodies were collected. Participants were monitored for the formation of anti-rHuPH20 antibodies using validated anti-rHuPH20 antibody detection assay (also known as the Screening and Confirmatory Binding Assay). Positive antibodies were defined as participants who had anti rHuPH20 antibody titer greater than or equal to (>=) 1:160 at least one time during treatment. | SAS included all enrolled participants who received TAK-771 administration at least once. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified categories. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1: Percentage of Participants With Clinical Worsening of CIDP | Clinical Worsening of CIDP was defined as a >=8 kPa decrease in hand grip strength in the more affected hand OR >=4 points decrease in Rasch Built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score at 2 consecutive time points. Hand grip strength was measured using the Martin vigorimeter by quantifying air pressure. The R-ODS was a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. R-ODS was comprised of 24 items that rate participant's functioning related to a variety of everyday tasks at moment of completion on a scale of 0 to 2 (where 0 indicates it is not possible for the respondent to perform the task and 2 means that task can be performed without difficulty). Total scores range from 0 to 48 and higher scores indicate greater ability to perform daily and social tasks. | FAS included all enrolled participants who received TAK-771 at least once. | Posted | Number | 95% Confidence Interval | percentage of participants | Epoch 1: Baseline until end of Epoch 1 or relapse (up to 6 months) |
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| Secondary | Epoch 1 and 2 (6 Months): Time to Relapse in Participants With CIDP | Time to relapse was defined as time from the date of the first SC administration of TAK-771 in Epoch 1 or 2 to the date of relapse. | FAS included all enrolled participants who received TAK-771 at least once. | Posted | Median | 95% Confidence Interval | weeks | Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1 |
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| Secondary | Epoch 1: Change From Pre-subcutaneous Treatment (Baseline) in R-ODS Total Score in Participants With CIDP | The R-ODS was a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. R-ODS was comprised of 24 items that rate participant's functioning related to a variety of everyday tasks at moment of completion on a scale of 0 to 2 (where 0 indicates it is not possible for the respondent to perform the task and 2 means that task can be performed without difficulty). Total scores range from 0 to 48 and higher scores indicate greater ability to perform daily and social tasks. | FAS included all enrolled participants who received TAK-771 at least once. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on scale | Epoch 1: Baseline up to 6 months |
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| Secondary | Epoch 1: Change From Pre-subcutaneous Treatment (Baseline) in an Average of Handgrip Strength of Both Hands in Participants With CIDP and MMN | The Martin Vigorimeter was used to assess grip strength in both hands. The instrument consisted of a compressible rubber ball that was connected to a manometer. When the rubber ball was squeezed, the force of compression was measured in kPa ranging from 0 to 160 kPa. Average of grip strength was defined as an average of the two maximum values: maximum of the 3 measurements in the more affected hand and the maximum of the 3 measurements in the less affected hand. | FAS included all enrolled participants who received TAK-771 at least once. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | kPa | Epoch 1: Baseline up to 6 months |
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| Secondary | Epoch 1: Change From Pre-subcutaneous Treatment (Baseline) Total Medical Research Council (MRC) Sum Score in Participants With MMN | The MRC sum score served as a measure of muscle strength. The following muscles on each side of the body were examined and the strength of each muscle was rated according to the MRC scale: deltoids, biceps, wrist extensors, iliopsoas, quadriceps, and anterior tibialis. The MRC scale ranged from 0 to 5, where: 0 = no visible contraction; 1 = visible contraction without movement of the limb; 2 = movement of the limb but not against gravity; 3 = movement against gravity over (almost) the full range; 4 = movement against gravity and resistance; and 5 = normal. All scores from both left and right side of the body were summed to obtain the total MRC sum score. The total MRC sum score ranged from 0 (paralysis) to 60 (normal strength) with higher score indication normal strength. | FAS included all enrolled participants who received TAK-771 at least once. | Posted | Mean | Standard Deviation | score on scale | Epoch 1: Baseline up to 6 months |
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| Secondary | Epoch 1: Number of MMN Participants With Increased Guy's Neurological Disability Scale (GNDS) Score in Upper Limb and Lower Limb Categories | GNDS was a questionnaire which consisted of 12 separate categories (4 to 8 questions per category). The categories included: cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and others. In the current study, only 2 categories; upper limb function and the lower limb function was used for assessment of the disability of participants with MMN. The severity of each subscale (including upper limb and lower limb) was graded from 0 (normal function) to 5 (total loss of function) based according to severity and impact on the individual. The total GNDS score was the sum of the 12 separate scores ranging between 0 and 60 with higher scores indicating loss of function. | FAS included all enrolled participants who received TAK-771 at least once. | Posted | Count of Participants | Participants | Epoch 1: Baseline up to 6 months |
|
|
Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epoch 1, Cohort 1 (CIDP): TAK-771 | TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse. | 0 | 19 | 0 | 19 | 16 | 19 |
| EG001 | Epoch 1, Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1. | 0 | 7 | 0 | 7 | 7 | 7 |
| EG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. | 0 | 16 | 0 | 16 | 11 | 16 |
| EG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. | 0 | 7 | 0 | 7 | 6 | 7 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Administration site erythema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Administration site extravasation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Administration site haemorrhage | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Administration site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic inflammatory demyelinating polyradiculoneuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatophytosis of nail | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion site discharge | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Multifocal motor neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Penile oedema | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2024 | Feb 24, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| OG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
|
|
| OG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
|
|
| OG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
|
|
| OG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
|
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TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
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| OG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
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| OG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
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| OG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
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| Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 |
TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
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| OG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
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| OG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
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TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1. |
| OG002 | Epoch 2 (6 Months), Cohort 1 (CIDP): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
| OG003 | Epoch 2 (6 Months), Cohort 2 (MMN): TAK-771 | TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary. |
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