Hepatitis CPhase 3NCT03004625
Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV
A Phase 3 study testing daclatasvir, asunaprevir and Ribavirin in people with Hepatitis C, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein (NS5A) resistance-associated variants. Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks will be prescribed. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- daclatasvir, asunaprevir and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2016to Apr 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment naïve, interferon-experienced, interferon-intolerant or interferon-ineligible, HCV genotype 1b patients with compensated liver disease.
- 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:
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- Liver biopsy within 2 years of Screening showing absence of cirrhosis
- Fibroscan within 6 months of Baseline with a result of ≤ 12.5 kilopascal
- History of chronic HCV infection > 6 months
- Aged at least 20 years
- HCV RNA of 10,000 IU/mL or greater
- 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
- 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.
- 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
- Ability to participate and willingness to give written informed consent and to comply with the study restrictions.
Who cannot join
- The existence of baseline NS5A RAV "Lycine 31 (L31F/I/M)" or "Tyrosine93 (Y93H)", by using direct-sequencing with RAV of > 20%.
- Hepatitis B virus or HIV co-infection.
- Patients with experience of ascites, oesophageal varices, or other evidence of hepatic decompensation, and/or hepatocellular carcinoma.
- History of organ transplantation, except cornea transplantation.
- Hemoglobin concentration < 12 g/dl for male, 11 g/dl for female
- Platelet count < 50,000/mm3
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- Prior direct antiviral agents (DAAs) experienced.
- 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)
- 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).
- Poorly controlled diabetes (Hemoglobin A1c value ≥ 8.5%) and endocrine condition.
- Total bilirubin >2 mg/dL, unless subject has a documented history of Gilbert's disease.
- Creatinine Clearance (CrCl) <30 mL/min (as estimated by Cockcroft and Gault)
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Efficacy and Safety of 12 Weeks of Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without Baseline NS5A Resistance-associated Variants (DARING)
A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein (NS5A) resistance-associated variants. Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks will be prescribed.
Read the detailed description
Twenty-four weeks of Daclatasvir plus Asunaprevir provided a high treatment efficacy in hepatitis C virus genotype 1b (HCV-1b) patients. Patients with non-structural protein 5A (NS5A) resistance associated variants (RAVs) would have an inferior response. The investigators anticipate that12 weeks of daclatasvir and asunaprevir plus ribavirin is highly effective for HCV Genotype 1b patients without baseline NS5A RAVs.
- Conditions
- Hepatitis C
- Being tested
- daclatasvir, asunaprevir, Ribavirin
- 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 Daklinza
to evaluate the treatment efficacy and safety of the drug in HCV patients
asunaprevirDrug
Also called Sunvepra
to evaluate the treatment efficacy and safety of the drug in HCV patients
RibavirinDrug
Also called Robatrol
to evaluate the treatment efficacy and safety of the drug in HCV patients
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | HCV-1b patients without baseline NS5A resistance-associated variants receiving Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks. (daclatasvir, asunaprevir plus ribavirin) Receives: Drug: daclatasvir; Drug: asunaprevir; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the treatment efficacy (SVR12) of 12 weeks of daclatasvir and asunaprevir plus ribavirin for HCV-1b patients without baseline RAVs
SVR12 is defined as undetectable HCV RNA 12 weeks throughout 12 weeks of post-treatment follow-up peroid
Measured: 6 months (including 3 months of treatment and 3 months of post-treatment follow-up peroid
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, China Medical University Hospital, National Cheng-Kung University Hospital
- Responsible party
- Sponsor
- Investigators
- Ming-Lung Yu, MD., PhD., Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004625
- Sponsor's protocol ID
- AI444-406
- Status last verified
- Jan 2019
- First submitted
- 21 Dec 2016
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Efficacy and Safety of 12 Weeks of Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without Baseline NS5A Resistance-associated Variants (DARING)
- ClinicalTrials.gov ID
- NCT03004625
- Acronym / sponsor ID
- AI444-406
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, China Medical University Hospital, National Cheng-Kung University Hospital
- Study start
- Nov 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein (NS5A) resistance-associated variants. Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks will be prescribed.
Detailed description
Twenty-four weeks of Daclatasvir plus Asunaprevir provided a high treatment efficacy in hepatitis C virus genotype 1b (HCV-1b) patients. Patients with non-structural protein 5A (NS5A) resistance associated variants (RAVs) would have an inferior response. The investigators anticipate that12 weeks of daclatasvir and asunaprevir plus ribavirin is highly effective for HCV Genotype 1b patients without baseline NS5A RAVs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Drug: daclatasvir, Drug: asunaprevir, Drug: RibavirinHCV-1b patients without baseline NS5A resistance-associated variants receiving Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks. (daclatasvir, asunaprevir plus ribavirin) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Treatment naïve, interferon-experienced, interferon-intolerant or interferon-ineligible, HCV genotype 1b patients with compensated liver disease.
- Patients with compensated liver cirrhosis will be capped at 40%.
- History of chronic HCV infection > 6 months
- Aged at least 20 years
- HCV RNA of 10,000 IU/mL or greater
Key exclusion criteria (13 listed)
- The existence of baseline NS5A RAV "Lycine 31 (L31F/I/M)" or "Tyrosine93 (Y93H)", by using direct-sequencing with RAV of > 20%.
- Hepatitis B virus or HIV co-infection.
- Patients with experience of ascites, oesophageal varices, or other evidence of hepatic decompensation, and/or hepatocellular carcinoma.
- History of organ transplantation, except cornea transplantation.
- Hemoglobin concentration < 12 g/dl for male, 11 g/dl for female
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 |
|---|---|---|
| daclatasvirAlso: Daklinzato evaluate the treatment efficacy and safety of the drug in HCV patients | Drug | Study Arm |
| asunaprevirAlso: Sunveprato evaluate the treatment efficacy and safety of the drug in HCV patients | Drug | Study Arm |
| RibavirinAlso: Robatrolto evaluate the treatment efficacy and safety of the drug in HCV patients | Drug | Study Arm |
Primary outcome
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
SVR12 is defined as undetectable HCV RNA 12 weeks throughout 12 weeks of post-treatment follow-up peroid
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Ming-Lung Yu, MD., PhD. principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing daclatasvir, asunaprevir and Ribavirin in people with Hepatitis C, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 15 inclusion and 13 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 9 Jan 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2019.