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

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Sovaprevir

ACH-3102

Ribavirin

Placebo

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Chronic Hepatitis C, Genotype 1, Hepatitis C, Liver Diseases, Hepatitis, Ribavirin, Antiviral Agents, Anti-infective Agents, Protease Inhibitors, NS5a Inhibitors, Viral

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and Females between ages 18 and 65
Chronic HCV infection
HCV genotype 1
HCV RNA > 10,000 IU/mL at screening.
Female patients must be willing to use two effective methods of contraception, one of which must be barrier method, during dosing period and six months after last dose of ribavirin. Females of childbearing potential must have a negative pregnancy test at screening and baseline.
Male patients must be willing to use an effective barrier method of contraception throughout the dosing period and for six months.
Signed and dated written informed consent form.
Willing to participate in all study activities and all study requirements (including effective contraception) during study period.
Treatment naïve subjects defined as subjects 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 (BMI) > 36.0
Pregnant or nursing (lactating) females, confirmed by a positive human chorionic gonadotropin (HCG) laboratory test or females contemplating pregnancy
Participation in any interventional clinical trial within 35 days prior to first study medication dose administration on Day 1
Known HIV-1 or HIV-2 infection/serology and/or positive Hepatitis B Surface Antigen (HBsAg)
Use of dietary supplements, grapefruit juice, herbal supplements, CYP2C8 substrates, CYP3A4 inducers and inhibitors, PGP inducers and substrates, OATP inhibitors and substrates, and potent inducers of other CYP enzymes within 14 days prior to dosing through 7 days following completion of study meds.
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)
History of clinical evidence of significant chronic cardiac disease ( specified in protocol)
ECG with any clinically significant abnormality.
Structural or functional cardiac abnormalities (specified in protocol)
History of COPD, emphysema, or other chronic lung disease.
Subjects currently abusing amphetamines, cocaine or opiates, or with ongoing alcohol abuse in the judgement of the investigator

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

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

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01849562

First Posted

April 18, 2013

Last Updated

August 7, 2023

Sponsor

Alexion

Collaborators

Achillion, a wholly owned subsidiary of Alexion

1. Study Identification

Unique Protocol Identification Number

NCT01849562

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alexion

Collaborators

Achillion, a wholly owned subsidiary of Alexion

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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.

Arm Title

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

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

Sovaprevir

Other Intervention Name(s)

ACH-0141625

Intervention Description

Nonstructural protein 3/4A protease inhibitor.

Intervention Type

Drug

Intervention Name(s)

ACH-3102

Intervention Description

Nonstructural protein 5A inhibitor.

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment

Description

Time Frame

Four weeks after the completion of treatment

Title

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

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 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). History of clinical evidence of significant chronic cardiac disease ( specified in protocol). Electrocardiogram with any clinically significant abnormality. Structural or functional cardiac abnormalities (specified in protocol). History of chronic obstructive pulmonary disease, emphysema, or other chronic lung disease. Participants currently abusing amphetamines, cocaine or opiates, or with ongoing alcohol abuse in the judgement of the investigator.

12. IPD Sharing Statement

Learn more about this trial

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

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