Phase 2
Completed N=33
A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT02993250 ↗
Enrolled (actual)
33
Serious AEs
3.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 15; 9 participants
Summary
The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1 or 2 chronic HCV infection with compensated cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
15; 9 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment |
100; 100 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment |
100; 100 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment |
100; 90.9 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
0; 0 | — |
| SECONDARY Percentage of Participants With On-treatment Failure |
0; 0 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Response |
4.5; 0; 4.5; 0; 4.5; 18.2 | — |
| SECONDARY Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ |
19.0; 18.6 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic hepatitis C virus (HCV) infection
- All participants must have HCV genotype 1 or 2 infection, determined at screening
- HCV ribonucleic acid (RNA) plasma levels greater than or equal to (>=)10,000 international units per Milliliter (IU/mL), determined at screening
- Direct-acting antiviral (DAA)-naive participants, defined as not having received treatment with any approved or investigational DAA drug for chronic HCV infection; prior HCV therapy consisting of interferon (IFN, pegylated or nonpegylated) with or without ribavirin (RBV) is allowed
- Participants without cirrhosis or with compensated cirrhosis
Exclusion Criteria
- Infection with HCV genotype - 3, 4, 5, or 6
- Co-infection with human immunodeficiency virus (HIV 1 or HIV 2 antibody positive) or hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive)
- Prior treatment with any investigational or approved HCV DAA, either in combination with PegIFN or IFN free
- Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection (immunoglobulin M), drug or alcohol related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha 1 antitrypsin deficiency, primary biliary cirrhosis, or any other non-HCV liver disease that is considered clinically significant by the investigator
- Evidence of hepatic decompensation as assessed with Child-Pugh Class B or C or any of the following: history or current clinical evidence of ascites, bleeding varices, or hepatic encephalopathy
Data sourced from ClinicalTrials.gov (NCT02993250). 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.