A PHASE 3, SAFETY AND EFFICACY STUDY OF BOCEPREVIR / PEGINTERFERON ALFA-2A/RIBAVIRIN IN CHRONIC HCV GENOTYPE 1 IL28B CC SUBJECTS (PROTOCOL NO. P07755) (ALSO KNOWN AS MK-3034-040-00).

Not Applicable

• Registration Number: PER-073-12
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. EACH SUBJECT MUST BE WILLING AND ABLE TO PROVIDE WRITTEN INFORMED CONSENT FOR THE TRIAL.
2. SUBJECTS MUST BE WILLING TO GIVE WRITTEN INFORMED CONSENT FOR PHARMACOGENETIC TESTING, AND ABLE TO ADHERE TO DOSE AND VISIT SCHEDULES.
NOTE: SUBJECTS WHO ARE UNWILLING TO SIGN THE INFORMED CONSENT FOR PHARMACOGENETIC TESTING MAY BE INCLUDED INTO THE TRIAL, HOWEVER, PHARMACOGENETIC SAMPLES MUST NOT BE OBTAINED.
3. EACH SUBJECT MUST BE ≥ 18YEARS OF AGE.
4. EACH SUBJECT´S WEIGHT MUST BE ≥ 40 KG AND ≤ 125 KG
5. SUBJECT MUST HAVE PREVIOUSLY DOCUMENTED CHC GENOTYPE 1 INFECTION. SUBJECTS WITH OTHER OR MIXED GENOTYPES ARE NOT ELIGIBLE. THE HCV-RNA RESULT OBTAINED FROM THE CENTRAL LABORATORY AT THE SCREENING VISIT MUST CONFIRM HCV GENOTYPE 1 INFECTION WITH HCV RNA ≥ 10,000 IU/RRIL
6. SUBJECTS MUST HAVE IL28B CC ALLELE GENE (WITH SNP RS12979860)
7. SUBJECT HAS HAD A LIVER BIOPSY WITHOUT EVIDENCE OF CIRRHOSIS AND HEPATOCELLULAR CARCINOMA. A LIVER BIOPSY DONE PRIOR TO SCREENING IS ACCEPTABLE IF:
. WITHIN 3 YEARS OF SCREENING AND THE RESULT WAS METAVIR (OR EQUIVALENT) STAGE 0 (FO) TO 2 (F2).
. WITHIN 1 YEAR OF SCREENING AND THE RESULT WAS STAGE 3 (F3).
IF THE PRIOR LIVER BIOPSY WAS OBTAINED OUTSIDE THE ACCEPTABLE WINDOWS, A REPEAT BIOPSY MAY BE PERFORMED, AND THE RESULTS MUST SHOW NO EVIDENCE OF CIRRHOSIS AND HEPATOCELLULAR CARCINOMA IN ORDER FOR THE SUBJECT TO BE RANDOMIZED IN THE STUDY.

Exclusion Criteria

1. SUBJECT IS UNDER THE AGE OF LEGAL CONSENT, IS MENTALLY OR LEGALLY INCAPACITATED, HAS SIGNIFICANT EMOTIONAL PROBLEMS AT THE TIME OF PRE-STUDY SCREENING VISIT OR EXPECTED DURING THE CONDUCT OF THE STUDY OR HAS A HISTORY OF A CLINICALLY SIGNIFICANT PSYCHIATRIC DISORDER WHICH, IN THE OPINION OF THE INVESTIGATOR, WOULD INTERFERE WITH THE STUDY PROCEDURES.
2. SUBJECTS CO-INFECTED WITH THE HUMAN IMMUNODEFICIENCY VIRUS (HIV) OR HEPATITS B VIRUS (HEPATITIS B SURFACE ANTIGEN [HBSAG] OR HIV POSITIVE).
3. SUBJECTS WHO WERE PREVIOUSLY TREATED WITH AN INTERFERON OR RIBAVIRIN REGIMEN OR HCV DIRECT ACTING ANTI-VIRAL REGIMEN.
4. TREATMENT FOR HEPATITIS C WITH ANY INVESTIGATIONAL MEDICATION. PRIOR TREATMENTS WITH HERBAL REMEDIES WITH KNOWN HEPATOTOXITY ARE EXCLUSIONARY. ALL HERBAL REMEDIES INCLUDING BUT NOT LIMITED TO ST. JOHN´S WORT (HYPERICUM PERFORATUM) USED FOR HEPATITIS C TREATMENT MUST BE DISCONTINUED BEFORE DAY 1. ONLY SILIBININ¬BASED PRODUCTS SUCH AS SILYMARIN (MILK THISTLE) ARE ALLOWED DURING THE TRIAL.

Study & Design

• Study Type: Interventional
• Study Design: Not specified