Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)

Hepatitis C, Chronic Clinical Trial

Official title:

A Phase 3 Clinical Trial to Study Short Duration Versus Standard Response-Guided Therapy With MK-3034 (SCH 503034)/Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Subjects With Chronic HCV Genotype 1 in Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945294
• Other study ID #: 3034-107
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2013
• Est. completion date: November 4, 2015

Study information

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

Clinical Trial Summary

The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: November 4, 2015
• Est. primary completion date: August 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• weigh = 40 kg and = 125 kg

• have CHC genotype 1 infection

• has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of cirrhosis and hepatocellular carcinoma

• must agree that the participant and the participant's partner will each use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations (for a female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential)

Exclusion Criteria:

• participates in any other interventional clinical trial within 30 days of the screening visit in this trial or intends to participate in another interventional clinical trial during participation in this trial

• is co-infected with human immunodeficiency virus (HIV) or hepatitis B virus

• has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis

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

• has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC

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

• has been previously treated with an interferon or ribavirin regimen or HCV direct acting anti-viral regimen, or treated for hepatitis C with any investigational medication

• taking/plans to take significant inducers of inhibitors of Cytochrome P450 3A4 (CYP3A4) substrates 2 weeks prior to start of study medications, or herbal supplements, including but not limited to St. John's Wort 2 weeks prior to start of study medications (Day 1)

• has pre-existing psychiatric condition(s)

• has a clinical diagnosis of substance abuse

• 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

• is pregnant or nursing (for female participant) or female partner intends to become pregnant (for male participant)

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Boceprevir
800 mg three times daily orally

Biological:
• Peg-interferon alfa-2b
1.5 mcg/kg weekly subcutaneously

Drug:
• Ribavirin
800-1400 mg twice-daily divided orally based on body weight

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 HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]	SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA < Lower Limit of Quantification [LLoQ]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.	Follow-up Week (FW) 12 (up to 40 weeks)
Secondary	Percentage of Participants With Undetectable HCV RNA Across Treatment	The percentage of participants with undetectable HCV RNA (HCV RNA	TW4, TW8, and TW12
Secondary	Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment	The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA	TW4, TW8, and TW12
Secondary	Percentage of Participants With Relapse	The percentage of viral relapse (defined as confirmed HCV RNA >15 IU/mL after End-of-Treatment [EOT]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.	From EOT to FW12 (up to 12 weeks)
Secondary	Percentage of Participants With Neutropenia	The percentage of participants with neutropenia (neutrophil count <0.75 x10^9/L) is summarized for each arm.	Up to 60 weeks
Secondary	Percentage of Participants With Anemia	The percentage of participants with anemia (hemoglobin [Hgb] <10 g/dL) was determined in each arm.	Up to 60 weeks
Secondary	Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported.	From TW1 through TW48
Secondary	Percentage of Participants With Treatment-Related Serious AEs (SAEs)	A SAE is any AE that results in death, is life threatening, results in persistent or significant disability, results in or prolongs an existing inpatient hospitalization, is a congenital birth defect, is a cancer, is associated with an overdose, or is another important medical event.	Up to 60 weeks