Hepatitis C, ChronicPhase 2NCT01849562

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

A Phase 2 study testing Sovaprevir, ACH-3102 and Ribavirin in people with Hepatitis C, Chronic, run by Alexion Pharmaceuticals, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Sovaprevir, ACH-3102 and Ribavirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: No sites listed yet
Study dates: Apr 2013to Apr 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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).

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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.

About this study

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

Conditions: Hepatitis C, Chronic
Being tested: Sovaprevir, ACH-3102, Ribavirin, Placebo
Keywords: Chronic Hepatitis C, Genotype 1, Hepatitis C, Liver Diseases, Hepatitis, Ribavirin, Antiviral Agents, Anti-infective Agents, Protease Inhibitors, NS5a Inhibitors, Viral
Medical subject headings: Hepatitis C, Chronic, Hepatitis C, Liver Diseases, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SovaprevirDrug
Also called ACH-0141625
Nonstructural protein 3/4A protease inhibitor.
ACH-3102Drug
Nonstructural protein 5A inhibitor.
RibavirinDrug
PlaceboDrug

Study groups in NCT01849562
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Apr 2014

First posted8 May 2013 (estimated)
Study startApr 2013
Primary completionNov 2013
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01849562
Sponsor's protocol ID: ACH102-007
Status last verified: Aug 2023
First submitted: 18 Apr 2013
Last updated: 29 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Active, not recruitingPhase 4
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
Chronic Hepatitis b

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01849562
Acronym / sponsor ID: ACH102-007
Conditions: Hepatitis C, Chronic
Keywords: Chronic Hepatitis C, Genotype 1, Hepatitis C, Liver Diseases, Hepatitis, Ribavirin, Antiviral Agents, Anti-infective Agents
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Achillion, a wholly owned subsidiary of Alexion
Study start: Apr 2013
Primary completion: Nov 2013 (actual)
Study completion: Apr 2014 (actual)
First posted: 8 May 2013 (estimated)
Results: Posted 4 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg	Active comparator	Drug: Sovaprevir, Drug: ACH-3102, Drug: RibavirinSovaprevir 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, ACH-3102 150/50 mg, RBV 1000 -1200 mg	Active comparator	Drug: Sovaprevir, Drug: ACH-3102, Drug: RibavirinSovaprevir 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	Placebo comparator	Drug: PlaceboPlacebo 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SovaprevirAlso: ACH-0141625Nonstructural protein 3/4A protease inhibitor.	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
ACH-3102Nonstructural protein 5A inhibitor.	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
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

Primary outcome

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).

Results and safety

Results posted to the registry on 4 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg	10	8
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg	10	10
Placebo	10	10

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

Time frame: Four weeks after the completion of treatment. Number. Unit: Percentage of participants with SVR4

Measure	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg n = 10	Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg n = 10	Placebo n = 10
Value	50	70	0

Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg vs Placebo: Risk Difference (RD): 50 (95% CI 1.8 to 82.7)
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg vs Placebo: Risk Difference (RD): 70 (95% CI 24.2 to 93.6)

Population analysed: The analysis population for SVR4 was the full analysis (FA) set, defined as all randomized participants who received at least 1 dose of the study drug and had at least 1 baseline/post HCV RNA assessment. For this study, the FA set and the safety population were the same.

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

Time frame: 12 weeks. Number. Unit: participants

Measure	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg n = 10	Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-2000 mg n = 10
Discontinuations due to AEs	0	0
Treatment Emergent G3/G4 AEs	0	0
Treatment Emergent G3/G4 Abnormalities	3	2
Clinically Significant ECGs	0	0

Population analysed: The analysis population for safety and tolerability was the safety population, defined as all randomized participants who received at least 1 dose of study drug. For this study, the safety population and the FA set were the same.

Adverse events

Time frame: AE data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg	0 of 10 (0%)	10 of 10 (100%)	Not reported
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg	1 of 10 (10%)	10 of 10 (100%)	Not reported
Placebo	0 of 10 (0%)	10 of 10 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Active, not recruitingPhase 4
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
Chronic Hepatitis b

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sovaprevir, ACH-3102 and Ribavirin in people with Hepatitis C, Chronic, run by Alexion Pharmaceuticals, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment (time frame: Four weeks after the completion of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01849562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.