Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)

Hepatitis C, Chronic Clinical Trial

Official title:

A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544920
• Other study ID #: P07755
• Secondary ID: 2011-001345-32MK
• Status: Completed
• Phase: Phase 3
• Start date: May 30, 2012
• Est. completion date: May 19, 2015

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to compare the efficacy of two boceprevir (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.

The regimens differ in the treatment for participants who achieve undetectable HCV ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV) 4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm 2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants with undetectable HCV RNA at Follow-Up (FU) Week 24.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 737
• Est. completion date: May 19, 2015
• Est. primary completion date: May 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is = 40 kg and = 125 kg.

• Documented CHC genotype 1 with HCV RNA =10,000 International Units (IU)/mL

• Has IL-28B CC allele gene

• 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).

Exclusion Criteria:

• Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] or HIV positive).

• Previously treated with an interferon and ribavirin regimen or HCV direct acting antiviral regimen.

• Treatment for hepatitis C with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity

• 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

• 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.

• Evidence of decompensated liver disease or hepatocellular carcinoma (HCC)

• Is diabetic and/or hypertensive with significant retinopathy

• 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.

• Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years

• Hemoglobin <12 g/dL for females and <13 g/dL for males

• Neutrophils <1,500/mm^3, or <1,200/mm^3 for participants of African descent

• Platelets <150,000/mm^3

• Direct bilirubin >1.5 x upper limit of normal (ULN) of the laboratory reference range.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Biological:
• peg-Interferon alfa-2a
peg-IFN (180 ug) was taken once weekly via subcutaneous injection.

Drug:
• Ribavirin
RBV 200 mg tablets taken by mouth at a total daily dose of 1,000 mg (body weight <75 kilograms [kg]) or 1,200 mg (body weight =75 kg) with total daily dose divided into 2 dosings.
• Boceprevir
Four 200 mg BOC capsules taken three times a day by mouth for a total daily dose of 2,400 mg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)	SVR24 rates were determined for all participants in Arm 1 and Arm 2. HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.	Up to Week 74
Secondary	Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24	SVR24 rates were determined for only participants that had undetectable HCV RNA at Week 4 of treatment (Arm 1a and Arm 2a). HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.	Up to Week 48