Phase 3
Completed N=63
Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)
Source: ClinicalTrials.gov NCT02203149 ↗Enrolled (actual)
63
Serious AEs
5.9%
Results posted
Oct 2016
Primary outcomePrimary: Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12) — 96.6 percentage of participants
◆ Published Evidence
Established
77citations · ~9 / year
The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study.
Summary
This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese participants with chronic hepatitis C virus (HCV) genotype 1 (GT1). Part I is a dose-finding study; in Part II, participants will be randomly assigned to receive grazoprevir at the dose determined in Part I in combination with elbasvir. The primary study hypothesis is that the percentage of treatment-naïve participants in the Immediate Treatment Arm of Part II who achieve sustained viral response at 12 weeks after the end of all treatment (SVR12) will be greater than the reference rate of 75%. A separate study arm for cirrhotic participants will also be included in Part II; these participants will receive grazoprevir at the determined dose in combination with elbasvir.
Linked Publications
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The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12) |
96.6 | — |
| PRIMARY Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks |
67.7; 74.2 | — |
| PRIMARY Part 1: Percentage of Participants That Discontinued Treatment Due to an AE |
0.0; 0.0 | — |
| PRIMARY Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks |
64.8; 67.6; 80.0 | — |
| PRIMARY Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE |
1.3; 1.4; 0.0 | — |
| SECONDARY Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time |
22.6; 35.5; 77.4; 83.9; 100.0; 100.0 | — |
| SECONDARY Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time |
61.3; 71.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment |
25.1; 39.7; 11.4; 70.5; 86.3; 65.7 | — |
| SECONDARY Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment |
60.8; 69.9; 60.0; 96.0; 98.6; 94.3 | — |
Eligibility Criteria
Inclusion Criteria
- Has documented chronic Japanese HCV genotype (GT) 1 with no evidence of non-typeable or mixed GT infection
- Is treatment-naïve, or intolerant or non-responder to prior anti-HCV interferon (IFN)-based treatment without direct acting antiviral (DAA) therapy, prior IFN-based treatment with DAA therapy, or prior DAA therapy
- Agrees to the use of contraception if a female of reproductive potential
Exclusion Criteria
- Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease
- Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV)
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
- Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC (Part 2 only)
- Has clinically-relevant drug or alcohol abuse within 12 months of screening
- Is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from Day 1 and continue throughout treatment and follow-up (or longer if dictated by local regulations)
- Has any of the following conditions:
- Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
- Poor venous access
- History of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease)
- History of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures
- Medical/surgical conditions that may result in a need for hospitalization during the period of the study
- Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, TNF antagonists, or other immunosuppressant drugs during the course of the trial
- Has chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
Data sourced from ClinicalTrials.gov (NCT02203149) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.