Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants

NCT01849562 | Completed Phase 2 Results DMC

• 1 other identifier: ACH102-007
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C, Chronic

Keywords

Chronic Hepatitis C; Genotype 1; Hepatitis C; Liver Diseases; Hepatitis; Ribavirin; Antiviral Agents; Anti-infective Agents; Protease Inhibitors; NS5a Inhibitors; Viral

Outcome Measures

Primary Outcomes (2)

• Incidence Of Sustained Virologic Response 4 Weeks (SVR4) 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.

  Four weeks after the completion of treatment

• Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants

  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).

  12 weeks

Study Arms (3)

Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg

ACTIVE COMPARATOR

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.

Drug: Sovaprevir; Drug: ACH-3102; Drug: Ribavirin

Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg

ACTIVE COMPARATOR

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.

Drug: Sovaprevir; Drug: ACH-3102; Drug: Ribavirin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Sovaprevir DRUG

Nonstructural protein 3/4A protease inhibitor.

Also known as: ACH-0141625

Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg; Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg

ACH-3102 DRUG

Nonstructural protein 5A inhibitor.

Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg; Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg

Ribavirin DRUG

Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg; Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic HCV infection.
• HCV GT-1.
• 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.

You may not qualify if:

• 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 1.
• 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.
• Use of bone marrow colony stimulating factor agents within 3 months prior to baseline.
• History of seizure disorder requiring ongoing medical therapy.
• History of known coagulopathy including hemophilia.
• History of hemoglobinopathy, including sickle cell anemia and thalassemia.
• History of immunologically mediated disease (specified in protocol).

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• Achillion, a wholly owned subsidiary of Alexion: collaborator

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Liver Diseases; Hepatitis

Interventions

odalasvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Alexion Pharmaceuticals Inc.
• Organization: Alexion Pharmaceuticals Inc.

clinicaltrials@alexion.com

855-752-2356

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 8, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: August 29, 2023
• Results First Posted: February 4, 2015

Record last verified: 2023-08