Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)

Hepatitis C, Chronic Clinical Trial

Official title:

Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390844
• Other study ID #: P07063
• Secondary ID: 2007-005151-4230
• Status: Completed
• Phase: Phase 3
• Start date: October 21, 2011
• Est. completion date: June 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

This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: June 19, 2015
• Est. primary completion date: June 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible.

• Liver biopsy with histology consistent with CHC and no other etiology.

• Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma

• Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV

• Weight between 40 kg and 125 kg, inclusive

• Of 'local' ancestral descent

• Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception

Exclusion Criteria:

• Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus.

• Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon.

• Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening.

• Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity.

• Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit.

• Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.

• Diabetes and/or hypertension with clinically significant ocular examination findings.

• Any condition the could interfere with participation in and completion of the trial.

• Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin).

• Pregnant or breast-feeding.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Boceprevir (BOC)
200 mg capsules, 800 mg three times daily by mouth
• Placebo to boceprevir
200 mg placebo capsules, 800 mg three times daily by mouth
• Peginterferon alfa-2b (PEG)
1.5 mcg/kg/week subcutaneously
• Ribavirin (RBV)
200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily
• Cross-Over Boceprevir Treatment
At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.

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 in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population	SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.	Follow-up Week 24
Primary	Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population	SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.	Follow-up Week 24
Secondary	Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population	SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.	Follow-up Week 24
Secondary	Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population	SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.	Follow-up Week 24
Secondary	Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8	Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)	Treatment Week 8
Secondary	Percentage of Participants in India Achieving EVR at Treatment Week 8	Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)	Treatment Week 8
Secondary	Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan	Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).	Up to 96 weeks
Secondary	Percentage of Participants With an AE of Anemia in India	Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).	Up to 96 weeks
Secondary	Percentage of Participants With an AE of Neutropenia in Korea and Taiwan	Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.	Up to 96 weeks
Secondary	Percentage of Participants With an AE of Neutropenia in India	Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.	Up to 96 weeks