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Hepatitis CPhase 4NCT02304159

Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics

A Phase 4 study testing daclatasvir, Sofosbuvir, Sovaldi and Ribavirin in people with Hepatitis C and Cirrhosis, run by Tarek I. Hassanein, M.D., FACP, FAG, AGAF at 1 site in United States.

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

This is a randomized, open label, single center safety and efficacy study. At least 40 cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatitis C, Cirrhosis
What is being tested?
daclatasvir, Sofosbuvir, Sovaldi and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
Jan 2015to Aug 2017
Phase
Phase 4
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed, written, informed consent must be available from the subject before any study-specific procedures are performed;
  • Male or female 18-75 years of age;
  • All of the following at least 6 months prior to screening visit:
  • Documented HCV infection based on history of a positive serum anti-HCV antibody test and/or detectable levels of HCV RNA >= 10,000 IU/mL, and
  • Documented HCV genotype 3.
  • Subjects with evidence of cirrhosis defined by either a liver biopsy <= 3 years from screening demonstrating a Metavir Fibrosis Score of F4 (or equivalent); OR Fibroscan® <= 1 year from screening > 12.5 kPa. If a subject is evaluated by more than one testing method, then the liver biopsy results take precedence;
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  • Women of childbearing potential (WOCBP) must:
  • have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
  • WOCBP must agree to follow instructions for method(s) of contraception for 7 months post-treatment completion.
  • Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the following duration for 7 months post-treatment completion.
  • Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% per year when used consistently and correctly.
  • At minimum the subject agrees to the use of two methods of contraception, with at least one method being highly effective as listed below:
  • Highly Effective Methods of Contraception
  • Male condoms with spermicide
  • Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena® by male subject's WOCBP partner. Female partners of male subjects participating in the study may use hormone-based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug. WOCBP cannot use hormonal contraception as one of the two methods of contraception because there are no data on the effectiveness of systemic hormonal contraceptives in women taking SOF. However, WOCBP can continue to use hormonal contraceptives, if necessary, in addition to 2 other non-hormonal methods of contraception
  • Nonhormonal IUDs, such as ParaGard®
  • Tubal Ligation
  • Vasectomy
  • Complete Abstinence - defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.
  • Less Effective Methods of Contraception
  • Diaphragm with spermicide
  • Cervical cap with spermicide
  • Vaginal sponge
  • Male condom without spermicide
  • Progestin only pills
  • Female condom; A male and female condom must not be used together
  • Azoospermic males, women who are not of childbearing potential and WOCBP who abstain from heterosexual activity on a continuous basis, are exempt from contraceptive requirements. However, WOCBP who abstain from heterosexual activity on a continuous basis must still undergo pregnancy testing.

Who cannot join

  • Subjects who lack capacity to consent for themselves;
  • HCV Genotypes other than GT-3 infection; mixed genotype infections are not permitted;
  • Liver histology consistent with any other co-existing cause of chronic liver disease (apart from fatty liver and/or Chronic Hepatitis B Virus);
  • Body Mass Index > 40 at the Screening visit;
  • Any of the following within one month of screening:
  • Uncontrolled diabetes;
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  • Unstable or uncontrolled thyroid disease (subjects requiring medication to control their thyroid disease are eligible if all other inclusion/exclusion criteria are met).
  • Any of the following within 6 months of screening visit, any of the following:
  • Decompensated liver disease, esophageal variceal bleeding, or a hepatic mass lesion suspicious for hepatocellular carcinoma (HCC);
  • Subjects who have been treated for HCV infection;
  • History of unstable or deteriorating cardiovascular or cerebrovascular disease;
  • Alcohol and/or drug.
  • QTcF ≥ 500 ms at the baseline visit.
  • Any of the following laboratory abnormalities within 8 weeks of the baseline visit:
  • Hemoglobin <8 g/dL;
  • Absolute neutrophil count <0.50 x 103 cells/μL;
  • Platelet count <25 x 103 cells/μL;
  • Total bilirubin >=3 mg/dL or >=34 mol/L (with the exception of subjects with Gilbert's syndrome);
  • Albumin <2.5g/dL;
  • Creatinine Clearance (CrCl) <=50 mL/min (as estimated by Cockcroft and Gault).
  • Serum ALT >=10 × ULN;
  • Alpha-fetoprotein >200ng/mL.
  • Prior exposure to NS5A inhibitors is prohibited but other classes and pegIFN/RBV are acceptable for treatment-experienced subjects;
  • Use of any prohibited or restricted treatment at least is five half-lives or 14 days (whichever is longer) of the first dose of study drug (refer to section 4.5);
  • History of cancer within 1 year of the screening visit with the exception of localized basal or squamous cell carcinoma;
  • Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug. (Subjects who have had cholecystectomy are permitted to enter the study);
  • Known HIV infection;
  • Confirmed, uncontrolled hypertension (any screening systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg should be excluded);
  • Presence or history of non-HCV chronic liver disease, including autoimmune hepatitis, alpha-1-antitrypsin deficiency, hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis and sclerosing cholangitis. Subjects with fatty liver and/or chronic hepatitis B virus in addition to HCV may be considered in the study;
  • Uncontrolled seizures disorder;
  • History of hemoglobinopathies, (e.g., thalassemia, sickle cell anemia, spherocytosis) or other cause of hemolytic anemia, including autoimmune causes;
  • Active disease at screening visit known to cause significant alteration in immunologic function including hematologic malignancy, sarcoidosis or autoimmune disorder (e.g., rheumatoid arthritis, systemic lupus erythematosis, leukemia, lymphoma, autoimmune thyroid disease, scleroderma, unstable psoriasis, and multiple sclerosis);
  • Pregnant or lactating women or women who plan to become pregnant during the study;
  • History of hypersensitivity to drugs with a similar biochemical structure to DCV or SOF or RBV;
  • Any other criteria or known contraindication that would exclude the subject from receiving SOF or RBV (per the local label) or DCV;
  • Inability to tolerate oral medication;
  • Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment or who would not comply with the requirements of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southern California Research Center

    Coronado, California, 92118

Other trials in United States

About this study

Official title: A Randomized Study to Evaluate the Safety and Efficacy of Adding Daclatasvir to the Combination of Sofosbuvir (SOF) and Ribavirin (RBV) for 16 Weeks Versus 24 Weeks in Cirrhotic Subjects With Chronic Hepatitis C Infection Genotype 3

This is a randomized, open label, single center safety and efficacy study. At least 40 cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product). Subjects will be randomized in a 1:1 to receive either:

  • Group A: 16 weeks of DCV/SOF/RBV
  • Group B: 24 weeks of DCV/SOF/RBV

Subjects will return to the study center at various time points throughout the 16 or 24 weeks of treatment in addition to 12 weeks post taking last dose of study drug to monitor safety and efficacy. These visits will be according to standard of care.

Being tested
daclatasvir, Sofosbuvir, Sovaldi, Ribavirin
Keywords
HCV, Genotype 3, Treatment naive, Treatment experienced
Medical subject headings
Hepatitis C, Fibrosis

What participants receive

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

  • daclatasvirDrug

    Also called DCV, BMS-790052, Daklinza

  • Sofosbuvir, SovaldiDrug

    Also called SOF

  • RibavirinDrug

    Also called RBV

Study groups in NCT02304159
Study groupRoleWhat they receive
Group A - 16 weeksExperimentalCombination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks
Receives: Drug: daclatasvir; Drug: Sofosbuvir, Sovaldi; Drug: Ribavirin
Group B - 24 weeksActive comparatorCombination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks
Receives: Drug: daclatasvir; Drug: Sofosbuvir, Sovaldi; Drug: Ribavirin

What is being measured

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

  1. Number of Participants With Adverse Events

    This field states the number of participants who had an adverse event

    Measured: From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.

  2. Number of Participants With Abnormal Safety Laboratory Tests (ALT and/or Total Bilirubin) That Required Discontinuing Study Drugs

    This field states the number of participants who had an abnormal ALT that required discontinuing study drugs and/or abnormal Total Bilirubin that required discontinuing study drugs.

    Measured: From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.

  3. Number of Participants With Undetectable HCV Virus 12 Weeks After Stopping Study Drugs

    Sustained Virologic Response (SVR) defined as undetectable HCV RNA 12 weeks after stopping study drugs.

    Measured: From baseline (start of study drugs) until 12 weeks after stopping study drugs

Timeline

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

  1. First posted1 Dec 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionAug 2017
  4. Study completionAug 2017

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02304159
Sponsor's protocol ID
AI444284
Status last verified
Apr 2019
First submitted
17 Nov 2014
Last updated
24 Apr 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing daclatasvir, Sofosbuvir, Sovaldi and Ribavirin in people with Hepatitis C and Cirrhosis, run by Tarek I. Hassanein, M.D., FACP, FAG, AGAF at 1 site in United States.

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 27 inclusion and 37 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 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 24 Apr 2019). 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?

Number of Participants With Adverse Events (time frame: From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.). The study lists 3 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 NCT02304159.

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 24 Apr 2019.

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