Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755 AM1)
- Conditions
- Health Condition 1: null- Chronic Hepatitis CHealth Condition 2: K73- Chronic hepatitis, not elsewhere classified
- Registration Number
- CTRI/2012/12/003200
- Lead Sponsor
- Merck Sharp and Dohme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 1250
1. Is more than equal to 40 kg and less than equal to 125 kg.
- Documented CHC genotype 1 with HCV RNA more than 10,000 International Units (IU)/mL
2. Has IL-28B CC allele gene
3. Has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and Fibrotest can also be used for staging of liver disease).
Note:upper age limit as per DCGI is 65 yrs.
1. Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] or HIV positive).
2. Previously treated with an interferon and ribavirin regimen or HCV direct acting antiviral regimen.
3. Treatment for hepatitis C with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity
4. Receiving any medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on Cytochrome P450 3A4 (CYP3A4/5) for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events
5. Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial.
6. Evidence of decompensated liver disease or hepatocellular carcinoma (HCC)
7. Is diabetic and/or hypertensive
8. Has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction.
9. Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
10. Hemoglobin is more than 12 g/dL for females and more than 13 g/dL for males
11. Neutrophils is more than 1,500/mm3, or more than 1,200/mm3 for participants of African descent
12. Platelets more is than 150,000/mm3
13. Direct bilirubin is less than 1.5 x upper limit of normal (ULN) of the laboratory reference range.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Number of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 [ Designated as safety issue: No ]Timepoint: Overall Number of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 [ Designated as safety issue: No ]
- Secondary Outcome Measures
Name Time Method umber of Participants Achieving SVR at Follow-up Week 24 Among Those Participants Who Had Achieved Rapid Virologic Response (RVR) [ Designated as safety issue: No ]Timepoint: Time Frame: Baseline to Follow-up Week 24