Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03004625
• Date of registration: 21/12/2016
• Prospective Registration: No
• Primary sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Public title: Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV
• Scientific title: Treatment Efficacy and Safety of 12 Weeks of Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without Baseline NS5A Resistance-associated Variants (DARING)
• Date of first enrolment: November 2016
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03004625
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: Ming-Lung Yu, MD., PhD.
• Affiliation: Kaohsiung Medical University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Treatment naïve, interferon-experienced, interferon-intolerant or
interferon-ineligible, HCV genotype 1b patients with compensated liver disease.

2. Patients with compensated liver cirrhosis will be capped at 40%.

Cirrhosis is defined as any one of the following:

- Liver biopsy showing cirrhosis

- Fibroscan indicative of cirrhosis as evidenced by a result > 12.5 kilopascal

Absence of cirrhosis is defined as any one of the following:

- Liver biopsy within 2 years of Screening showing absence of cirrhosis

- Fibroscan within 6 months of Baseline with a result of = 12.5 kilopascal

3. History of chronic HCV infection > 6 months

4. Aged at least 20 years

5. HCV RNA of 10,000 IU/mL or greater

6. Negative serum or urine pregnancy test result (sensitivity of 25 international units
or better) for women with childbearing potential within the 24-hour period before the
first dose of study drugs

7. Female patients with childbearing potential must agree to use two reliable forms of
effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine
device, spermicides, or sponge), at least 1 of which must be a physical barrier
method, during treatment and for at least 6 months following the last dose of
ribavirin.

8. A hormonal contraception (in lieu of non-hormonal) plus a physical barrier method can
be used after end of treatment. All men with female partners of childbearing potential
must use two reliable forms of effective contraception (combined) during treatment and
for 6 months following the last dose of ribavirin

9. Ability to participate and willingness to give written informed consent and to comply
with the study restrictions.

Exclusion Criteria:

1. The existence of baseline NS5A RAV "Lycine 31 (L31F/I/M)" or "Tyrosine93 (Y93H)", by
using direct-sequencing with RAV of > 20%.

2. Hepatitis B virus or HIV co-infection.

3. Patients with experience of ascites, oesophageal varices, or other evidence of hepatic
decompensation, and/or hepatocellular carcinoma.

4. History of organ transplantation, except cornea transplantation.

5. Hemoglobin concentration < 12 g/dl for male, 11 g/dl for female

6. Platelet count < 50,000/mm3

7. Prior direct antiviral agents (DAAs) experienced.

8. History of active malignancy within the last 5 years, with the exception of localized
or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin)

9. History of severe cardiac disease (e.g., New York Heart Association Functional Class
III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia's
requiring ongoing treatment, unstable angina or other unstable, uncontrolled or
significant cardiovascular disease within 6 months).

10. Poorly controlled diabetes (Hemoglobin A1c value = 8.5%) and endocrine condition.

11. Total bilirubin >2 mg/dL, unless subject has a documented history of Gilbert's
disease.

12. Creatinine Clearance (CrCl) <30 mL/min (as estimated by Cockcroft and Gault)

13. Pregnant or lactating women.



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: asunaprevir

Drug: Ribavirin

Drug: daclatasvir

Primary Outcome(s)

To determine the treatment efficacy (SVR12) of 12 weeks of daclatasvir and asunaprevir plus ribavirin for HCV-1b patients without baseline RAVs [Time Frame: 6 months (including 3 months of treatment and 3 months of post-treatment follow-up peroid]

Secondary Outcome(s)

To evaluate the number of participants with treatment-related adverse events of 12 weeks of daclatasvir and asunaprevir plus ribavirin for HCV-1b patients without baseline RAVs. [Time Frame: 3 months]

Secondary ID(s)

AI444-406

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chang Gung Memorial Hospital

China Medical University Hospital

Taipei Veterans General Hospital, Taiwan

National Cheng-Kung University Hospital

National Taiwan University Hospital