Hepatitis CPhase 3NCT02673489

A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection

A Phase 3 study testing DCV, SOF and RBV in people with Hepatitis C, run by Bristol-Myers Squibb at 19 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C
What is being tested?: DCV, SOF and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 19 sitesin 2 countries
Study dates: 15 Mar 2016to 26 May 2017
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Genotype 3 HCV
HCV RNA ≥10000 IU (International Unit)/mL
Compensated Liver Cirrhosis
BMI 18-40 kg/m2
Previously treated for HCV or never treated for HCV

Who cannot join

Infection with HCV other than Genotype 3. Mixed infection of any genotype
Evidence of decompensated liver disease
Previous exposure to NS5A inhibitors
Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

United States12 sites

Texas Clinical Research Institute
Arlington, Texas, 76012
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
Digestive Disease Associates, PA
Catonsville, Maryland, 21228
Ruth Rothstein Core Center
Chicago, Illinois, 60612
Methodist Transplant Physicians
Dallas, Texas, 75203
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Keck Medical Center Of USC
Los Angeles, California, 90033
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
University Gastroenterology
Providence, Rhode Island, 02905
Bon Secours St. Mary's Hospital of Richmond, Inc
Richmond, Virginia, 23226
The Texas Liver Institute
San Antonio, Texas, 78215
University Of California, San Francisco
San Francisco, California, 94143

Other trials in United States

Canada7 sites

Local Institution
Calgary, Alberta, T2N 4Z6
Local Institution
Edmonton, Alberta, T6G 2P4
Local Institution
Montreal, Quebec, H3T 1E2
Local Institution
Regina, Saskatchewan, S4O 0W5
Local Institution
Toronto, Ontario, M5G 2C4
Local Institution
Vancouver, British Columbia, V6Z 2K5
Local Institution
Victoria, British Columbia, V8V 3P9

Other trials in Canada

About this study

Official title: A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection

Conditions: Hepatitis C
Being tested: DCV, SOF, RBV
Medical subject headings: Hepatitis C

What participants receive

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

DCVDrug
SOFDrug
RBVDrug

Study groups in NCT02673489
Study group	Role	What they receive
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)	Experimental	Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks. Receives: Drug: DCV; Drug: SOF; Drug: RBV

What is being measured

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

Percentage of Participants With Sustained Virologic Response (SVR12)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.
Measured: Week 12

Secondary outcomes (3)

Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.
Measured: Week 12 (Follow-up period)
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. SVR12 is based on Next Value Carried Backwards approach.
Measured: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks)
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up.
Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria.
Measured: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24

Timeline

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

15 Mar 201626 May 2017

First posted4 Feb 2016 (estimated)
Study start15 Mar 2016
Primary completion2 Mar 2017
Study completion26 May 2017

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 Hepatitis CStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02673489
Sponsor's protocol ID: AI444-379
Other IDs: 2015-004331-12, 2015
Status last verified: Apr 2018
First submitted: 28 Jan 2016
Last updated: 8 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Poordad F, Shiffman ML, Ghesquiere W, Wong A, Huhn GD, Wong F, Ramji A, Shafran SD, McPhee F, Yang R, Noviello S, Linaberry M; ALLY-3C study team. Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C). Antivir Ther. 2019;24(1):35-44. doi: 10.3851/IMP3278.
PubMed 30382942

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?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection
ClinicalTrials.gov ID: NCT02673489
Acronym / sponsor ID: AI444-379
Conditions: Hepatitis C
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 15 Mar 2016 (actual)
Primary completion: 2 Mar 2017 (actual)
Study completion: 26 May 2017 (actual)
First posted: 4 Feb 2016 (estimated)
Results: Posted 29 Mar 2018

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)	Experimental	Drug: DCV, Drug: SOF, Drug: RBVOral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.

Who may qualify

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

Key inclusion criteria (5 listed)

Genotype 3 HCV
HCV RNA ≥10000 IU (International Unit)/mL
Compensated Liver Cirrhosis
BMI 18-40 kg/m2
Previously treated for HCV or never treated for HCV

Key exclusion criteria (4 listed)

Infection with HCV other than Genotype 3. Mixed infection of any genotype
Evidence of decompensated liver disease
Previous exposure to NS5A inhibitors
Other protocol defined inclusion/exclusion criteria could apply

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
DCV	Drug	Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
SOF	Drug	Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
RBV	Drug	Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)

Primary outcome

Percentage of Participants With Sustained Virologic Response (SVR12)
Time frame: Week 12
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.

3 secondary outcomes

Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms
Time frame: Week 12 (Follow-up period)
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Time frame: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks)
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Time frame: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24

Results and safety

Results posted to the registry on 29 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Naive	54	49
Treatment Experienced	24	21

Primary outcome: Percentage of Participants With Sustained Virologic Response (SVR12)

Time frame: Week 12. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	HCV Treatment Naive n = 54	HCV Treatment Experienced n = 24
Value	92.6 (82.1 to 97.9)	75.0 (53.3 to 90.2)

Population analysed: All treated participants

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall: Daclatasvir(DCV) + Sofosbuvir(SOF) + Ribavirin(RBV)	8 of 78 (10.3%)	63 of 78 (80.8%)	0 of 78
HCV Treatment Naive	4 of 54 (7.4%)	44 of 54 (81.5%)	0 of 54
HCV Treatment Experienced	4 of 24 (16.7%)	19 of 24 (79.2%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30382942Poordad F, Shiffman ML, Ghesquiere W, Wong A, Huhn GD, Wong F, Ramji A, Shafran SD, McPhee F, Yang R, Noviello S, Linaberry M; ALLY-3C study team. Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C). Antivir Ther. 2019;24(1):35-44. doi: 10.3851/IMP3278.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

19 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DCV, SOF and RBV in people with Hepatitis C, run by Bristol-Myers Squibb at 19 sites in 2 countries.

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 5 inclusion and 4 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 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 29 Mar 2018). 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?

Percentage of Participants With Sustained Virologic Response (SVR12) (time frame: Week 12). 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 NCT02673489, 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 8 May 2018.