Chronic Hepatitis CPhase 2NCT02068222
A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection
A Phase 2 study testing ABT-450/ritonavir (r), ABT-530 and Ribavirin (RBV) in people with Chronic Hepatitis C and Hepatitis C Virus, run by AbbVie.
Trial summary
The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C, Hepatitis C Virus
- What is being tested?
- ABT-450/ritonavir (r), ABT-530 and Ribavirin (RBV)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Mar 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2.
- Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.
- Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
- Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.
Who cannot join
- History of severe, life-threatening or other significant sensitivity to any drug.
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
- Prior therapy for the treatment of HCV.
- Any current or past clinical evidence of cirrhosis.
- Any cause of liver disease other than chronic HCV-infection.
- HCV genotype co-infection with any other HCV genotype.
- Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
About this study
Official title: An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection
The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
Read the detailed description
Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus
- Being tested
- ABT-450/ritonavir (r), ABT-530, Ribavirin (RBV)
- Keywords
- Hepatitis C, HCV, Interferon Free, Chronic Hepatitis C, Hepatitis C virus, Hepatitis C Genotype 3
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-450/ritonavir (r)Drug
Also called ABT-450 also known as paritaprevir
Tablet
ABT-530Drug
Also called pibrentasvir
Tablet
Ribavirin (RBV)Drug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| ABT-450/r and ABT-530 plus RBV | Experimental | ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Receives: Drug: ABT-450/ritonavir (r); Drug: ABT-530; Drug: Ribavirin (RBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Measured: 12 weeks after last dose of study drug
Secondary outcomes (3)
The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)
SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.
Measured: 24 weeks after last dose of study drug
The Percentage of Subjects With Virologic Failure During Treatment
Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.
Measured: Up to Treatment Week 12
The Percentage of Subjects With Post-Treatment Relapse
Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.
Measured: Within 12 weeks after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionMar 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Armen Asatryan, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068222
- Sponsor's protocol ID
- M14-213
- Status last verified
- Jan 2018
- First submitted
- 19 Feb 2014
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Poordad F, Landis CS, Asatryan A, Jackson DF 3rd, Ng TI, Fu B, Lin CW, Yao B, Kort J. High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection. Liver Int. 2016 Aug;36(8):1125-32. doi: 10.1111/liv.13067. Epub 2016 Feb 3.
PubMed 26778412
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection
- ClinicalTrials.gov ID
- NCT02068222
- Acronym / sponsor ID
- M14-213
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus
- Keywords
- Hepatitis C, HCV, Interferon Free, Chronic Hepatitis C, Hepatitis C virus, Hepatitis C Genotype 3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Posted 2 Feb 2017
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 is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
Detailed description
Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABT-450/r and ABT-530 plus RBV | Experimental | Drug: ABT-450/ritonavir (r), Drug: ABT-530, Drug: Ribavirin (RBV)ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2.
- Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.
- Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
- Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.
Key exclusion criteria (7 listed)
- History of severe, life-threatening or other significant sensitivity to any drug.
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
- Prior therapy for the treatment of HCV.
- Any current or past clinical evidence of cirrhosis.
- Any cause of liver disease other than chronic HCV-infection.
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 |
|---|---|---|
| ABT-450/ritonavir (r)Also: ABT-450 also known as paritaprevirTablet | Drug | ABT-450/r and ABT-530 plus RBV |
| ABT-530Also: pibrentasvirTablet | Drug | ABT-450/r and ABT-530 plus RBV |
| Ribavirin (RBV)Tablet | Drug | ABT-450/r and ABT-530 plus RBV |
Primary outcome
The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
Time frame: 12 weeks after last dose of study drug
SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
3 secondary outcomes
The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)
Time frame: 24 weeks after last dose of study drug
The Percentage of Subjects With Virologic Failure During Treatment
Time frame: Up to Treatment Week 12
The Percentage of Subjects With Post-Treatment Relapse
Time frame: Within 12 weeks after the last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26778412Poordad F, Landis CS, Asatryan A, Jackson DF 3rd, Ng TI, Fu B, Lin CW, Yao B, Kort J. High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection. Liver Int. 2016 Aug;36(8):1125-32. doi: 10.1111/liv.13067. Epub 2016 Feb 3.
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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.
Armen Asatryan, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-450/ritonavir (r), ABT-530 and Ribavirin (RBV) in people with Chronic Hepatitis C and Hepatitis C Virus, run by AbbVie.
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 4 inclusion and 7 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 22 Feb 2018. 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. 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 2 Feb 2017). 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?
The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) (time frame: 12 weeks after last dose of study drug). 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 NCT02068222, which also lists 1 linked publication.
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 22 Feb 2018.