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..
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
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
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Responsible party
- Sponsor
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
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.
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.
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
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.
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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?
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.