Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-arm, multicenter study of boceprevir (BOC) in combination with peginterferon plus ribavirin (PEG/RBV) in adult chronic hepatitis C (CHC) genotype 1 participants who completed their per-protocol defined treatment and did not achieve sustained viral response (SVR) while in the PEG/RBV control arm(s) of an Schering-Plough Research Institute (SPRI) study of BOC combination therapy. Participants who are able to enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are to receive BOC+ PEG/RBV for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who are not able to enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are to receive PEG/RBV for 4 weeks followed by BOC+ PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOC + PEG/RBV | Experimental | Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous protocol received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boceprevir | Drug | Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24); | SVR24 was defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week (FW) 24. SVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies. | From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through Follow-Up Week (FW) 24 (up to 68 weeks) |
| Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL | AE= any untoward medical occurrence in a participant administered a pharmaceutical product/biologic (at any dose), whether or not considered related to the use of that product. Included the onset of new illness and the exacerbation of pre-existing conditions. Clinically significant laboratory abnormalities that required intervention/additional therapy, required a dose modification, or were associated with a clinical manifestation were considered AEs. SAE= any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, or was a congenital anomaly or birth defect. | From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Early Virologic Response (EVR) | EVR was defined as undetectable HCV-RNA at TW 12 of BOC + PEG/RBV. EVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies. | From TW 1 to TW 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
All participant exclusion criteria from the SPRI clinical study in which the participant participated prior to qualifying for this study will apply in this study, EXCEPT for the following:
Participants who had the opportunity to receive boceprevir in the previous study.
Participants requiring discontinuation, interruption, or dose reduction of RBV for more than 2 weeks in the previous study.
Participants requiring discontinuation, interruption, or dose reduction of PEG to less than two-thirds of the assigned starting dose for more than 2 weeks in the previous study.
Participants who experienced a life-threatening SAE considered at least possibly related to study drugs by the investigator or sponsor in the previous study.
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24362076 | Result | Vierling JM, Davis M, Flamm S, Gordon SC, Lawitz E, Yoshida EM, Galati J, Luketic V, McCone J, Jacobson I, Marcellin P, Muir AJ, Poordad F, Pedicone LD, Albrecht J, Brass C, Howe AY, Colvard LY, Helmond FA, Deng W, Treitel M, Wahl J, Bronowicki JP. Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response. J Hepatol. 2014 Apr;60(4):748-56. doi: 10.1016/j.jhep.2013.12.013. Epub 2013 Dec 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
168 participants enrolled and received at least one dose of study medication. Participants were categorized by prior treatment response on the referring study: prior null response, prior partial response, prior relapse, or other.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BOC + PEG/RBV: Prior Null Responders | Participants who achieved "null" response (defined as <2-log10 decrease and detectable HCV RNA at Treatment Week (TW) 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Peginterferon alfa-2b (SCH 54031) | Biological | Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC) |
|
|
| Ribavirin (SCH 18908) | Drug | Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID). |
|
|
| FG001 | BOC + PEG/RBV: Prior Partial Responders | Participants who achieved "partial" response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
| FG002 | BOC + PEG/RBV: Prior Relapsers | Participants who achieved "prior relapse" (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
| FG003 | BOC + PEG/RBV: Other | Participants who were characterized as "Other" (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-Up Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BOC + PEG/RBV: Prior Null Responders | Participants who achieved "null" response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
| BG001 | BOC + PEG/RBV: Prior Partial Responders | Participants who achieved "partial" response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
| BG002 | BOC + PEG/RBV: Prior Relapsers | Participants who achieved "prior relapse" (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
| BG003 | BOC + PEG/RBV: Other | Participants who were characterized as "Other" (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
| BG004 | 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 | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24); | SVR24 was defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week (FW) 24. SVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies. | All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 "Other" participants were included in the calculations for "BOC + PEG/RBV: All " (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis. | Posted | Number | percentage of participants | From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through Follow-Up Week (FW) 24 (up to 68 weeks) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL | AE= any untoward medical occurrence in a participant administered a pharmaceutical product/biologic (at any dose), whether or not considered related to the use of that product. Included the onset of new illness and the exacerbation of pre-existing conditions. Clinically significant laboratory abnormalities that required intervention/additional therapy, required a dose modification, or were associated with a clinical manifestation were considered AEs. SAE= any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, or was a congenital anomaly or birth defect. | All Treated Participants: All enrolled participants who received at least one dose of treatment. | Posted | Number | percentage of participants | From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Early Virologic Response (EVR) | EVR was defined as undetectable HCV-RNA at TW 12 of BOC + PEG/RBV. EVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies. | All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 "Other" participants were included in the calculations for "BOC + PEG/RBV: All " (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis. | Posted | Number | percentage of participants | From TW 1 to TW 12 |
|
From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks)
Only treatment-emergent AEs occurring on the present study (NCT00910624) and AEs occurring during the follow-up period of the present study are reported.
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 | All Treated Participants | Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. | 18 | 168 | 161 | 168 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Chest pain | General disorders | MedDRA 15.1 |
| ||
| Oedema peripheral | General disorders | MedDRA 15.1 |
| ||
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 15.1 |
| ||
| Sarcoidosis | Immune system disorders | MedDRA 15.1 |
| ||
| Appendicitis | Infections and infestations | MedDRA 15.1 |
| ||
| Cellulitis | Infections and infestations | MedDRA 15.1 |
| ||
| Injection site abscess | Infections and infestations | MedDRA 15.1 |
| ||
| Lobar pneumonia | Infections and infestations | MedDRA 15.1 |
| ||
| Staphylococcal infection | Infections and infestations | MedDRA 15.1 |
| ||
| Joint injury | Injury, poisoning and procedural complications | MedDRA 15.1 |
| ||
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 |
| ||
| Salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
| ||
| Acute psychosis | Psychiatric disorders | MedDRA 15.1 |
| ||
| Mood swings | Psychiatric disorders | MedDRA 15.1 |
| ||
| Arterial occlusive disease | Vascular disorders | MedDRA 15.1 |
| ||
| Femoral artery occlusion | Vascular disorders | MedDRA 15.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 |
| ||
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 |
| ||
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Dysgeusia | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 |
| ||
| Asthenia | General disorders | MedDRA 15.1 |
| ||
| Chills | General disorders | MedDRA 15.1 |
| ||
| Fatigue | General disorders | MedDRA 15.1 |
| ||
| Influenza like illness | General disorders | MedDRA 15.1 |
| ||
| Injection site reaction | General disorders | MedDRA 15.1 |
| ||
| Irritability | General disorders | MedDRA 15.1 |
| ||
| Pain | General disorders | MedDRA 15.1 |
| ||
| Pyrexia | General disorders | MedDRA 15.1 |
| ||
| Weight decreased | Investigations | MedDRA 15.1 |
| ||
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 |
| ||
| Disturbance in attention | Nervous system disorders | MedDRA 15.1 |
| ||
| Dizziness | Nervous system disorders | MedDRA 15.1 |
| ||
| Headache | Nervous system disorders | MedDRA 15.1 |
| ||
| Depression | Psychiatric disorders | MedDRA 15.1 |
| ||
| Insomnia | Psychiatric disorders | MedDRA 15.1 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 |
|
Investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor, and further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Lost to Follow-up |
|
| Reasons Unrelated To Assigned Treatment |
|
| Withdrawal by Subject |
|
| Withdrew Due To Retreatment Opportunity |
|
| Administrative |
|
| Male |
|
|
|
| OG002 | BOC + PEG/RBV: Prior Relapsers | Participants who achieved "prior relapse" (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
| OG003 | BOC + PEG/RBV: All | Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up. |
|
|