Skip to main content
OpenTrials
Completed

NCT Number: NCT01945294

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)

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).

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

boceprevir

Drug

800 mg three times daily orally

Other names: MK-3034

PEG-interferon alfa-2b

Biological

1.5 mcg/kg weekly subcutaneously

Other names: PegIntron

Ribavirin

Drug

800-1400 mg twice-daily divided orally based on body weight

Other names: Rebetol

Primary outcomes

  1. 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]

    Time frame: Follow-up Week (FW) 12 (up to 40 weeks)

    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.

Secondary outcomes

  1. Percentage of Participants With Undetectable HCV RNA Across Treatment

    Time frame: TW4, TW8, and TW12

    The percentage of participants with undetectable HCV RNA (HCV RNA <LLoQ) at TW4, TW8, and TW12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.

  2. Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment

    Time frame: TW4, TW8, and TW12

    The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA <LLoQ) at Week 4, Week 8, and Week 12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.

  3. Percentage of Participants With Relapse

    Time frame: From EOT to FW12 (up to 12 weeks)

    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.

  4. Percentage of Participants With Neutropenia

    Time frame: Up to 60 weeks

    The percentage of participants with neutropenia (neutrophil count <0.75 x10^9/L) is summarized for each arm.

  5. Percentage of Participants With Anemia

    Time frame: Up to 60 weeks

    The percentage of participants with anemia (hemoglobin [Hgb] <10 g/dL) was determined in each arm.

  6. Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)

    Time frame: From TW1 through TW48

    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.

  7. Percentage of Participants With Treatment-Related Serious AEs (SAEs)

    Time frame: Up to 60 weeks

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 18, 2013
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.