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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01544920
• Date of registration: 28/02/2012
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)
• Scientific title: A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects
• Date of first enrolment: May 30, 2012
• Target sample size: 737
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01544920
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, France, Germany, Guatemala, Hong Kong, Israel, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Singapore, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C, Chronic

Intervention(s)

Drug: Boceprevir

Drug: Ribavirin

Biological: peg-Interferon alfa-2a

Primary Outcome(s)

Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24) [Time Frame: Up to Week 74]

Secondary Outcome(s)

Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24 [Time Frame: Up to Week 48]

Secondary ID(s)

PHRR131022-000133

CTRI/2012/12/003200

2011-001345-32

MK-3034-040

P07755

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/05/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01544920