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Hepatitis CPhase 3ALLY 3NCT02032901

Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV

A Phase 3 study testing Daclatasvir and Sofosbuvir in people with Hepatitis C, run by Bristol-Myers Squibb at 31 sites in 2 countries.

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

To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection 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?
Daclatasvir and Sofosbuvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
31 sitesin 2 countries
Study dates
Jan 2014to Dec 2014
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

  • Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
  • Subjects chronically infected with hepatitis C virus (HCV) genotype 3
  • Subjects who are HCV treatment-naive
  • Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
  • HCV RNA ≥10,000 IU/mL at screening

Who cannot join

  • HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
  • Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
  • Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
  • Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Trial locations and contacts

31 sites in 2 countries.

31 sites in 2 countries

United States30 sites

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates, PA

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • Mercy Medical Center, Inc.

    Baltimore, Maryland, 21202

  • Digestive Disease Associates, P.A.

    Baltimore, Maryland, 21229

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida, 32720

  • Dupage Medical Group

    Downers Grove, Illinois, 60515

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • University of Florida Hepatology Research

    Gainesville, Florida, 32610

  • Gastro One

    Germantown, Tennessee, 38138

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Scripps Clinic

    La Jolla, California, 92037

  • Peter J Ruane MD Inc

    Los Angeles, California, 90036

  • National Research Institute

    Los Angeles, California, 90057

  • Anthony M. Mills MD Inc

    Los Angeles, California, 90069

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Gastrointestinal Specialists Of Georgia

    Marietta, Georgia, 30060

  • Clinical Research Centers Of America

    Murray, Utah, 84123

  • Huntington Medical Research Institutes

    Pasadena, California, 91105

  • Main Line Gastroenterology Associates Pc

    Perkasie, Pennsylvania, 18944

  • Center For Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • Premier Medical Group Of The Hudson Valley, Pc

    Poughkeepsie, New York, 12601

  • Lifetree Clinical Research

    Salt Lake City, Utah, 84106

  • American Research Corporation

    San Antonio, Texas, 78215

  • Precision Research Institute, LLC

    San Diego, California, 92114

  • Medical Associates Research Group

    San Diego, California, 92123

  • Quest Clinical Research

    San Francisco, California, 94115

  • Southwest Care Center

    Santa Fe, New Mexico, 87505

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico1 site

  • Fundacion De Investigacion De Diego

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection

To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection

Conditions
Hepatitis C
Being tested
Daclatasvir, Sofosbuvir
Medical subject headings
Hepatitis C

What participants receive

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

  • DaclatasvirDrug

    Also called BMS-790052

  • SofosbuvirDrug

Study groups in NCT02032901
Study groupRoleWhat they receive
A1:Daclatasvir + Sofosbuvir in treatment-naive subjectsExperimentalDaclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Receives: Drug: Daclatasvir; Drug: Sofosbuvir
A2:Daclatasvir + Sofosbuvir in treatment-experienced subjectsExperimentalDaclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Receives: Drug: Daclatasvir; Drug: Sofosbuvir

What is being measured

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

  1. Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)

    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.

    Measured: Week 12 (Follow-up period)

  2. Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)

    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

    Measured: Week 12 (Follow-up period)

Secondary outcomes (8)

  1. Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)

    RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

    Measured: Week 4

  2. Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)

    cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

    Measured: Week 12

  3. Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)

    EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

    Measured: Up to the end of treatment (up to 24 weeks)

  4. Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)

    Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

    Measured: Week 1, 2, 6, 8 (treatment period)

  5. Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)

    Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

    Measured: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)

  6. Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)

    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.

    Measured: Baseline, Week 12 (Follow-up period)

  7. Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)

    Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

    Measured: Week 12 (Follow-up period)

  8. Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)

    AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.

    Measured: From Day 1 first dose to last dose plus 7 days

Timeline

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

  1. First posted10 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionSep 2014
  4. Study completionDec 2014

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02032901
Sponsor's protocol ID
AI444-218
Acronym
ALLY 3
Status last verified
Sep 2015
First submitted
9 Jan 2014
Last updated
1 Oct 2015
Data monitoring committee
No

Publications

  • Kowdley KV, Nelson DR, Lalezari JP, Box T, Gitlin N, Poleynard G, Rabinovitz M, Ravendhran N, Sheikh AM, Siddique A, Bhore R, Noviello S, Rana K. On-treatment HCV RNA as a predictor of sustained virological response in HCV genotype 3-infected patients treated with daclatasvir and sofosbuvir. Liver Int. 2016 Nov;36(11):1611-1618. doi: 10.1111/liv.13165. Epub 2016 Jun 16.

    PubMed 27188960

  • Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, Freilich BF, Younes ZH, Harlan W, Ghalib R, Oguchi G, Thuluvath PJ, Ortiz-Lasanta G, Rabinovitz M, Bernstein D, Bennett M, Hawkins T, Ravendhran N, Sheikh AM, Varunok P, Kowdley KV, Hennicken D, McPhee F, Rana K, Hughes EA; ALLY-3 Study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015 Apr;61(4):1127-35. doi: 10.1002/hep.27726. Epub 2015 Mar 10.

    PubMed 25614962

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daclatasvir and Sofosbuvir in people with Hepatitis C, run by Bristol-Myers Squibb at 31 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 5 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 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Puerto Rico. 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 14 Sep 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?

Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) (time frame: Week 12 (Follow-up period)). 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 NCT02032901, which also lists 2 linked publications.

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 1 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.

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