A Phase 2a Trial to Evaluate the Safety, Tolerability, and Efficacy of 12 Weeks of Sovaprevir, ACH-0143102 and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotype-1 Viral Infection
Overview
- Phase
- Phase 2
- Intervention
- Sovaprevir
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Alexion Pharmaceuticals, Inc.
- Enrollment
- 30
- Primary Endpoint
- Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with sovaprevir, ACH-0143102, and ribavirin (RBV) in genotype-1 (GT-1), treatment-naive, hepatitis C virus (HCV) participants.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic HCV infection.
- •HCV ribonucleic acid \> 10,000 international units/milliliter at screening.
- •Female participants must be willing to use 2 effective methods of contraception, one of which must be a barrier method, during the dosing period and 6 months after the last dose of RBV. Females of childbearing potential must have a negative pregnancy test at screening and baseline.
- •Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months.
- •Signed and dated written informed consent form.
- •Willing to participate in all study activities and all study requirements (including effective contraception) during the study period.
- •Treatment-naïve participants were defined as those participants who have never received pegylated interferon, RBV, or a direct-acting anti-viral agent for the treatment of chronic HCV infection.
- •A liver biopsy within the last 3 years without evidence of cirrhosis.
Exclusion Criteria
- •Body mass index \> 36.0 kilograms/meter squared.
- •Pregnant or nursing (lactating) female participants confirmed by a positive human chorionic gonadotropin laboratory test or contemplating pregnancy.
- •Participation in any interventional clinical trial within 35 days prior to first study medication dose administration on Day
- •Known human immunodeficiency virus (HIV)-1 or HIV-2 infection/serology and/or positive hepatitis B surface antigen.
- •Use of dietary supplements, grapefruit juice, herbal supplements, cytochrome P450 (CYP) 2C8 substrates, CYP3A4 inducers and inhibitors, P-glycoprotein inducers and substrates, organic-anion-transporting polypeptide inhibitors and substrates, and potent inducers of other CYP enzymes within 14 days prior to dosing through 7 days following completion of study medications.
- •Clinically significant laboratory abnormality at screening (specified in protocol).
- •Other forms of liver disease.
- •History of severe or uncontrolled psychiatric disease.
- •History of malignancy of any organ system, treated or untreated within the past 5 years.
- •History of major organ transplantation.
Arms & Interventions
Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg
Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
Intervention: Sovaprevir
Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg
Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
Intervention: ACH-3102
Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg
Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
Intervention: Ribavirin
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
Intervention: Sovaprevir
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
Intervention: ACH-3102
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg
Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
Intervention: Ribavirin
Placebo
Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment
Time Frame: Four weeks after the completion of treatment
Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo.
Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants
Time Frame: 12 weeks
To determine the safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV treatment in participants with chronic genotype-1 (GT-1) HCV, the following criteria will be used: the number of participants with discontinuations due to adverse events (AEs), treatment-emergent Grade 3/Grade 4 (G3/G4) AEs, treatment-emergent G3/G4 laboratory abnormalities, and clinically significant electrocardiograms (ECGs).