DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Boceprevir (BOC) (Drug); PegIntron (PEG) (Biological); Ribavirin (RBV) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.

Clinical Details

Official title: PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 (HCV-1) Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)

Percent of Participants Who Achieved Sustained Virologic Response (SVR)

Secondary outcome:

Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA

Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop

Percent of Participants With Virologic Response Prior to Amendment 2

Peak Plasma Concentration of Boceprevir (BOC)

Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period

Trough Plasma Concentration Level

Change in Alanine Aminotransferase (ALT) Levels

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)

Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Key inclusion criteria:

- Documented infection with chronic hepatitis C (CHC), genotype 1.

- Documented failure to respond to an adequate course of treatment (minimum 12 weeks)

with peginterferon-alfa plus ribavirin (failure defined as <2 log drop in HCV-RNA after 12 weeks of therapy or those who never become Hepatitis C Virus Ribonucleic Acid (HCV)-RNA negative)

- No evidence of cirrhosis on liver biopsy.

- Results of physical examination and laboratory tests within specified ranges.

- Abstinence from use of abused substances.

Key exclusion criteria:

- Women who are pregnant or nursing a child.

- Patients with cirrhosis, co-infection with Hepatitis B or human immunodeficiency

virus (HIV), and African-American patients (by protocol amendment 2, African-American patients can enroll).

- Previous treatment with any Hepatitis C Virus (HCV) polymerase or protease inhibitor.

- Patients who relapsed following response to previous treatment.

- Evidence of advanced liver disease, or liver disease from a cause other than CHC.

- Pre-existing psychiatric condition.

Locations and Contacts

Additional Information

Starting date: September 2005
Last updated: November 10, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017