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The study was terminated due to funding constraints
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The purpose of this study is to assess efficacy of a human monoclonal antibody against Hepatitis C (MBL-HCV1) combined with telaprevir [part 1: an HCV protease inhibitor] or sofosbuvir [part 2: an Hepatitis C virus NS5B polymerase inhibitor] in a 56 day treatment duration in patients undergoing liver transplantation due to chronic HCV infection. There is an option for extended study treatment through 84 days if viral load is undetectable at day 56.
Administration of Intravenous infusions of MBL-HCV1 (50mg/kg) human monoclonal antibody during the first 14 days post-transplantation: three infusions on day 0 (1-4 hours prior to the anhepatic phase, during the anhepatic phase, and 4-12 hours post-reperfusion). Daily infusions on days 1 through 7, weekly infusions on day 14 ± 2, day 21 ± 3, and day 28 ± 3, followed by biweekly infusions on day 42 ± 3 and on day 56 ± 3 if criteria for the stopping rule are not met. For those subjects electing extended treatment, the administration of additional infusions on day 70 ± 3 and day 84 ± 3 will be performed. Subjects receive an oral direct-acting antiviral (telaprevir in Part 1 and sofosbuvir in Part 2) starting no earlier than day 3 post-transplant and no later than day 7; dosing continuing through day 56 unless criteria for the stopping rule are met. Subjects who elect to receive extended study treatment for a total of 12 weeks continue telaprevir in Part 1 or sofosbuvir in Part 2 through day 84 ± 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: MBL-HCV1 and Telaprevir | Experimental |
| |
| Part 2: MBL-HCV1 and Sofosbuvir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBL-HCV1 | Biological | 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Undetectable HCV RNA at Day 56 Post Liver Transplantation | The primary outcome was to determine if MBL-HCV1 in combination with the oral direct-acting antiviral could reduce HCV viral RNA to undetectable at day 56 post transplant and prevent the new liver from becoming productively infected. Undetectable HCV RNA was defined as the level below the lower limit of detection (LLOD) of an FDA-approved polymerase chain reaction (PCR) assay. HCV RNA was quantified by PCR (e.g., COBAS®AmpliPrep/ COBAS® TaqMan® HCV Test manufactured by Roche or equivalent) at each study site | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Study Treatment by Number of Adverse Events Reported | Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms and/or required therapy that was new or enhanced from baseline. Solicited adverse reactions included the occurrence of the following during or immediately after the infusion: arthralgia, chills, dyspnea, fatigue, fever, headache, nausea, hives, or rash. The presence of any of these symptoms (new or worsening from baseline) was documented as an adverse event. In addition, subjects were asked at all scheduled study visits to report any other adverse events. Adverse events were summarized by System Organ Class (SOC) using MedDRA (version 14.1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Sustained Virologic Response (SVR) at Week 12 and Week 24 | Number of subjects with sustained virologic response (defined as HCV RNA concentration below the limit of detection) at 12 and 24 weeks post-treatment was examined as an exploratory endpoint in subjects whose HCV RNA remained undetectable at the 6 week post-treatment safety follow-up visit. Those subjects that had detectable HCV RNA at the end of safety follow-up period were not assessed for SVR 12 and SVR 24. Those subjects achieving an SVR12 were assessed for the durability of the response at 24 weeks after the end of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28127942 | Background | Smith HL, Chung RT, Mantry P, Chapman W, Curry MP, Schiano TD, Boucher E, Cheslock P, Wang Y, Molrine DC. Prevention of allograft HCV recurrence with peri-transplant human monoclonal antibody MBL-HCV1 combined with a single oral direct-acting antiviral: A proof-of-concept study. J Viral Hepat. 2017 Mar;24(3):197-206. doi: 10.1111/jvh.12632. Epub 2016 Nov 7. |
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Reasons for exclusion from study treatment included receipt of an ineligible organ at time of transplant, awaiting transplant at time study enrollment stopped, became ineligible, withdrew consent and subject expired prior to organ offer.
Chronically infected patients with HCV genotype 1a (Part 1) or genotype 1 (Part 2) scheduled to undergo a liver transplantation were recruited at 5 U.S. transplantation centers between May 2012 and August 2015. Eleven subjects were enrolled. Ten subjects were transplanted and received study intervention in the study (8 in Part 1) and (2 in Part 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: MBL-HCV1 and Telaprevir | MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 Telaprevir (Part 1): Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Telaprevir (Part 1) | Drug | Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
|
|
| Sofosbuvir (Part 2) | Drug | One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
|
|
| Day 0 start of first infusion through Day 56 or six weeks after last dose of study treatment whichever is later, up to approximately 126 days |
| Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 10, 14, 28, 35, 42, 49, 70, 84 and 98 in Liver Transplant Recipients and for Those Subjects Receiving an Additional 4 Weeks of Treatment at Study Day 105, 112 and 126 | The number of subjects with undetectable HCV RNA by study visit day was analyzed utilizing a "last value carried forward" (LVCF) strategy so that each study visit day had data from (8 subjects in Part 1 and 2 subjects in Part 2), effectively imputing the information for the subjects who had missing data due to a missed study visit, HCV RNA measured with a non-FDA approved assay, or completion of all required post-treatment study visits. The last recorded HCV RNA status for a subject (detectable vs undetectable) was used for the next missing level (in ascending visit number order) until a new HCV RNA level was recorded at a later visit. Serum HCV RNA was measured by Quantitative RT-PCR using an FDA-approved quantitative assay | Day 7, 10, 14, 28, 35, 42, 49, 70, 84, 98, 105, 112 and 126 |
| Change in Viral Load Between Baseline Pre-transplant HCV RNA Levels and Study Day 7, 10, 14, 28, 35, 42, 49, 56, 70, 84 and 98 in Liver Transplant Recipients | Serum HCV RNA was measured by quantitative RT-PCR. The change in log 10 IU/mL HCV viral load from baseline was compared with pre-transplant HCV RNA level and evaluated for each subject at each study visit. Change in the level of HCV RNA in serum, log10(IU/mL), is defined as the difference between the level measured at Baseline and the specified time point. If HCV RNA was not detected by the PCR assay, the lower level of detection of the PCR assay was used for the calculation | Baseline pre-transplant and study Day 7, 10, 14, 28, 35, 42, 49, 56, 70, 84 and 98 |
| Number of Participants With HCV Resistance-associated Variants to MBL-HCV1 and Oral Direct-acting Antivirals Before and After Receipt of Study Treatment | Conventional sequencing was performed on HCV RNA isolated from a subset of serum samples obtained at baseline, at the time of viral rebound, and at the end of study in subjects who did not achieve a sustained virologic response. The targets of both the MBL-HCV1 antibody (E1/E2 glycoprotein) and telaprevir (NS3) were sequenced. The data displays the number of subjects with > 20% resistance associated variants (RAV) reported for the target MBL-HCV1 and/or Direct-acting Antiviral (DAA) | Pre-transplant, time of viral rebound (assessed from Day 7-Day 56 of treatment), end of study (up to day 126) in subjects who did not achieve a sustained virologic response (SVR) |
| 12 weeks after the end of treatment (SVR12) and 24 weeks after the end of treatment 12 weeks and 24 weeks post-treatment |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| FG001 |
| Part 2: MBL-HCV1 and Sofosbuvir |
MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
| Infused |
|
| Transplanted |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The ten subjects (8 in Part 1 and 2 in Part 2) who initiated study infusions, underwent liver transplantation and received an oral direct-acting antiviral (telaprevir in Part 1 or sofosbuvir in Part 2) were included in the analysis population
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: MBL-HCV1 and Telaprevir | MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 Telaprevir (Part 1): Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
| BG001 | Part 2: MBL-HCV1 and Sofosbuvir | MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Hepatocellular Carcinoma | The number of participants with a history of hepatocellular carcinoma prior to liver transplantation was reported | Count of Participants | Participants |
| |||||||||||||||
| Baseline serum HCV RNA concentration | Participants' pre-transplant baseline serum HCV RNA concentration was measured by quantitative RT-PCR (reverse-transcriptase PCR) | Mean | Full Range | Log10 IU/mL |
|
| 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 | Number of Subjects With Undetectable HCV RNA at Day 56 Post Liver Transplantation | The primary outcome was to determine if MBL-HCV1 in combination with the oral direct-acting antiviral could reduce HCV viral RNA to undetectable at day 56 post transplant and prevent the new liver from becoming productively infected. Undetectable HCV RNA was defined as the level below the lower limit of detection (LLOD) of an FDA-approved polymerase chain reaction (PCR) assay. HCV RNA was quantified by PCR (e.g., COBAS®AmpliPrep/ COBAS® TaqMan® HCV Test manufactured by Roche or equivalent) at each study site | The ten subjects (8 in Part 1 and 2 in Part 2) who initiated study infusions, underwent liver transplantation and received an oral direct-acting antiviral (telaprevir in Part 1 or sofosbuvir in Part 2) were included in the analysis population | Posted | Count of Participants | Participants | Day 56 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Safety and Tolerability of Study Treatment by Number of Adverse Events Reported | Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms and/or required therapy that was new or enhanced from baseline. Solicited adverse reactions included the occurrence of the following during or immediately after the infusion: arthralgia, chills, dyspnea, fatigue, fever, headache, nausea, hives, or rash. The presence of any of these symptoms (new or worsening from baseline) was documented as an adverse event. In addition, subjects were asked at all scheduled study visits to report any other adverse events. Adverse events were summarized by System Organ Class (SOC) using MedDRA (version 14.1) | The ten subjects (8 in Part 1 and 2 in Part 2) who initiated study infusions, underwent liver transplantation and received an oral direct-acting antiviral (telaprevir in Part 1 or sofosbuvir in Part 2) were included in the analysis population. | Posted | Number | Events | Day 0 start of first infusion through Day 56 or six weeks after last dose of study treatment whichever is later, up to approximately 126 days |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 10, 14, 28, 35, 42, 49, 70, 84 and 98 in Liver Transplant Recipients and for Those Subjects Receiving an Additional 4 Weeks of Treatment at Study Day 105, 112 and 126 | The number of subjects with undetectable HCV RNA by study visit day was analyzed utilizing a "last value carried forward" (LVCF) strategy so that each study visit day had data from (8 subjects in Part 1 and 2 subjects in Part 2), effectively imputing the information for the subjects who had missing data due to a missed study visit, HCV RNA measured with a non-FDA approved assay, or completion of all required post-treatment study visits. The last recorded HCV RNA status for a subject (detectable vs undetectable) was used for the next missing level (in ascending visit number order) until a new HCV RNA level was recorded at a later visit. Serum HCV RNA was measured by Quantitative RT-PCR using an FDA-approved quantitative assay | The ten subjects (8 in Part 1 and 2 in Part 2) who initiated study infusions, underwent liver transplantation and received an oral direct-acting antiviral (telaprevir in Part 1 or sofosbuvir in Part 2) were included in the analysis population | Posted | Number | participants | Day 7, 10, 14, 28, 35, 42, 49, 70, 84, 98, 105, 112 and 126 |
| |||||||||||||||||||||||||||||||
| Secondary | Change in Viral Load Between Baseline Pre-transplant HCV RNA Levels and Study Day 7, 10, 14, 28, 35, 42, 49, 56, 70, 84 and 98 in Liver Transplant Recipients | Serum HCV RNA was measured by quantitative RT-PCR. The change in log 10 IU/mL HCV viral load from baseline was compared with pre-transplant HCV RNA level and evaluated for each subject at each study visit. Change in the level of HCV RNA in serum, log10(IU/mL), is defined as the difference between the level measured at Baseline and the specified time point. If HCV RNA was not detected by the PCR assay, the lower level of detection of the PCR assay was used for the calculation | The ten subjects (8 in Part 1 and 2 in Part 2) who initiated study infusions, underwent liver transplantation and received an oral direct-acting antiviral (telaprevir in Part 1 or sofosbuvir in Part 2) were included in the analysis population | Posted | Mean | Full Range | Log10 IU/mL | Baseline pre-transplant and study Day 7, 10, 14, 28, 35, 42, 49, 56, 70, 84 and 98 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HCV Resistance-associated Variants to MBL-HCV1 and Oral Direct-acting Antivirals Before and After Receipt of Study Treatment | Conventional sequencing was performed on HCV RNA isolated from a subset of serum samples obtained at baseline, at the time of viral rebound, and at the end of study in subjects who did not achieve a sustained virologic response. The targets of both the MBL-HCV1 antibody (E1/E2 glycoprotein) and telaprevir (NS3) were sequenced. The data displays the number of subjects with > 20% resistance associated variants (RAV) reported for the target MBL-HCV1 and/or Direct-acting Antiviral (DAA) | The ten subjects (8 in Part 1 and 2 in Part 2) who initiated study infusions, underwent liver transplantation and received an oral direct-acting antiviral (telaprevir in Part 1 or sofosbuvir in Part 2) were included in the analysis population | Posted | Number | Participants with > 20 % RAV | Pre-transplant, time of viral rebound (assessed from Day 7-Day 56 of treatment), end of study (up to day 126) in subjects who did not achieve a sustained virologic response (SVR) |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Subjects With Sustained Virologic Response (SVR) at Week 12 and Week 24 | Number of subjects with sustained virologic response (defined as HCV RNA concentration below the limit of detection) at 12 and 24 weeks post-treatment was examined as an exploratory endpoint in subjects whose HCV RNA remained undetectable at the 6 week post-treatment safety follow-up visit. Those subjects that had detectable HCV RNA at the end of safety follow-up period were not assessed for SVR 12 and SVR 24. Those subjects achieving an SVR12 were assessed for the durability of the response at 24 weeks after the end of treatment | Of 8 subjects in Part 1, 2 had undetectable HCV RNA at 6 wk post-treatment. Therefore, at wk 12 (day 168), per protocol, 2 were analyzed. 1 had detectable HCV RNA at wk 12. Per protocol, the subject did not require a 24 wk visit. The other subject had undetectable HCV RNA at wk 12. Therefore, only 1 subject was analyzed at wk 24 (day 252). This subject had undetectable HCV RNA at wk 24. 2 subjects in Part 2 had undetectable HCV RNA at 12 & 24 wks. 2 subjects were analyzed at the 12 & 24 wks | Posted | Number | participants | 12 weeks after the end of treatment (SVR12) and 24 weeks after the end of treatment 12 weeks and 24 weeks post-treatment |
|
Day 0 start of first infusion through Day 56 or six weeks after last dose of study treatment whichever is later, up to approximately 126 days
Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. The following adverse reactions were solicited during or immediately after the infusion: arthralgia, chills, dyspnea, fatigue, fever, headache, nausea, hives, or rash. Summarized by System Organ Class (SOC) and Preferred Term (PT)
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 | Part 1: MBL-HCV1 and Telaprevir | MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 Telaprevir (Part 1): Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 | 7 | 8 | 8 | 8 | ||
| EG001 | Part 2: MBL-HCV1 and Sofosbuvir | MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GENERALISED OEDEMA | General disorders | MedDRA (14.1) | Systematic Assessment | AND ADMINISTRATION SITE CONDITIONS |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (14.1) | Systematic Assessment | AND ADMINISTRATION SITE CONDITIONS |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| LIVER TRANSPLANT REJECTION | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| TRANSPLANT REJECTION | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| GLOSSODYNIA | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (14.1) | Systematic Assessment | AND ADMINISTRATION SITE CONDITIONS |
|
| FATIGUE | General disorders | MedDRA (14.1) | Systematic Assessment | AND ADMINISTRATION SITE CONDITIONS |
|
| OEDEMA | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment | AND ADMINISTRATION SITE CONDITIONS |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (14.1) | Systematic Assessment | AND ADMINISTRATION SITE CONDITIONS |
|
| PYREXIA | General disorders | MedDRA (14.1) | Systematic Assessment | AND ADMINISTRATION SITE CONDITIONS |
|
| BILE DUCT STENOSIS | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| CANDIDIASIS | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| LUNG INFECTION PSEUDOMONAL | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| INCISION SITE COMPLICATION | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| INCISION SITE ERYTHEMA | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| INCISION SITE PAIN | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| INCISION SITE PRURITUS | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| OPERATIVE HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| VOCAL CORD PARALYSIS | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| TESTICULAR SWELLING | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| HERNIA REPAIR | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| REPERFUSION INJURY | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | MassBiologics | 617-474-3000 | Mblclinicaldirector@Umassmed.edu |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C486464 | telaprevir |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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 |
|
| OG001 |
| Part 2: MBL-HCV1 and Sofosbuvir |
MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
|
|
| OG001 | Part 2: MBL-HCV1 and Sofosbuvir | MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
|
|
|
|
MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
|
|
| OG001 | Part 2: MBL-HCV1 and Sofosbuvir | MBL-HCV1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 Sofosbuvir (Part 2): One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 |
|
|