Hepatitis CRHACE 1NCT02098616
Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus
A study testing DCV/ASV/BMS-791325 and DCV/ASV/BMS-791325 + RBV in people with Hepatitis C, run by Timothy Morgan, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without 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/ASV/BMS-791325 and DCV/ASV/BMS-791325 + RBV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Feb 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects chronically infected with HCV genotype 1a
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)
Who cannot join
- Evidence of cirrhosis
- Liver or any other organ transplant
- Current or known history of cancer within 5 years prior to enrollment
- Documented or suspected hepatocellular carcinoma (HCC)
- Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Long Beach Healthcare System
Long Beach, California, 90822
About this study
Official title: RHACE 1: Rapid HepAtitis C Elimination Trial - A Pilot Evaluation of Twice Daily Fixed Dose Combination Asunaprevir +Daclatasvir + BMS-791325 ± Weight Based Ribavirin in Treatment-Naïve, Non-cirrhotic Patients With Chronic Genotype 1a Hepatitis-C for Eight, Six or Four Weeks
The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.
- Conditions
- Hepatitis C
- Being tested
- DCV/ASV/BMS-791325, DCV/ASV/BMS-791325 + RBV
- Keywords
- Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, RNA Virus Infections, Antiviral Agents, Drug Resistance, Viral
- Medical subject headings
- Hepatitis C, Hepatitis, Hepatitis, Chronic, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, RNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCV/ASV/BMS-791325Drug
Also called Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day
DCV/ASV/BMS-791325 + RBVDrug
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks Receives: Drug: DCV/ASV/BMS-791325 |
| Arm 2 | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 6, 8 or 12 weeks Receives: Drug: DCV/ASV/BMS-791325 |
| Arm 3 | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks Receives: Drug: DCV/ASV/BMS-791325 |
| Arm A | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 8 weeks Receives: Drug: DCV/ASV/BMS-791325 + RBV |
| Arm B | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 6, 8 or 12 weeks Receives: Drug: DCV/ASV/BMS-791325 + RBV |
| Arm C | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 4 weeks Receives: Drug: DCV/ASV/BMS-791325 + RBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response
Proportion of treated subjects in each enrolled arm with sustained virologic response (SVR)12. SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Week 12
Measured: Post treatment week 12
Secondary outcomes (7)
Safety
On treatment safety, as measured by frequency of serious adverse events (SAEs) and adverse events (AEs), discontinuations due to AEs, and rates and grades of select laboratory abnormalities including liver function tests and hematology laboratory abnormalities in each arm
Measured: Up to end of treatment (+7 days)
Sustained virologic response
Proportion of treated subjects in each arm with SVR2, SVR4 and SVR 24, defined as HCV RNA < lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Weeks, 2, 4, and 24 respectively
Measured: 2, 4 and 24 weeks post-treatment
Post treatment virologic response
To assess the proportion of subjects who achieve sustained virologic response (SVR) 2, SVR4 and SVR24.
Measured: post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24)
On treatment virologic response
To assess antiviral activity, as measured by the proportion of subjects who achieve HCV RNA <lower limit of detection (LLOD) and/or < lower limit of quantification (LLOQ) at each on treatment visit.
Measured: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12
Virologic failure
To assess the proportion of subjects with virologic failure (including on treatment virologic breakthrough and relapse) and evaluate the emergence of viral resistant mutations.
Measured: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24
Day 2 positive predictive value
To assess the predictive value of Day 2 virologic response on sustained virologic response (SVR) 12
Measured: Post treatment Week 12
Interferon lambda genotype and virologic response
To compare the virologic response of subjects by genotype for interferon (IFN) lambda variants [' IL28B' and IFNL4-ΔG]
Measured: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2016
- Study completionFeb 2016
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Morgan, MD
- Sponsor type
- University, hospital or other
- Collaborators
- VA Long Beach Healthcare System, National Cancer Institute (NCI), Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Timothy Morgan, MD, Southern California Institute for Research and Education
- Investigators
- Timothy R. Morgan, MD, Principal investigator, VA Long Beach Healthcare System/Southern California Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098616
- Sponsor's protocol ID
- IRB #1285
- Other IDs
- AI443-128
- Acronym
- RHACE 1
- Status last verified
- Apr 2016
- First submitted
- 25 Mar 2014
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RHACE 1: Rapid HepAtitis C Elimination Trial - A Pilot Evaluation of Twice Daily Fixed Dose Combination Asunaprevir +Daclatasvir + BMS-791325 ± Weight Based Ribavirin in Treatment-Naïve, Non-cirrhotic Patients With Chronic Genotype 1a Hepatitis-C for Eight, Six or Four Weeks
- ClinicalTrials.gov ID
- NCT02098616
- Acronym / sponsor ID
- RHACE 1 / IRB #1285
- Conditions
- Hepatitis C
- Keywords
- Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, RNA Virus Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Timothy Morgan, MDUniversity, hospital or other
- Collaborators
- VA Long Beach Healthcare System, National Cancer Institute (NCI), Bristol-Myers Squibb
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 28 Mar 2014 (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.
The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: DCV/ASV/BMS-791325Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks |
| Arm 2 | Experimental | Drug: DCV/ASV/BMS-791325Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 6, 8 or 12 weeks |
| Arm 3 | Experimental | Drug: DCV/ASV/BMS-791325Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks |
| Arm A | Experimental | Drug: DCV/ASV/BMS-791325 + RBVFixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 8 weeks |
| Arm B | Experimental | Drug: DCV/ASV/BMS-791325 + RBVFixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 6, 8 or 12 weeks |
| Arm C | Experimental | Drug: DCV/ASV/BMS-791325 + RBVFixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects chronically infected with HCV genotype 1a
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)
Key exclusion criteria (5 listed)
- Evidence of cirrhosis
- Liver or any other organ transplant
- Current or known history of cancer within 5 years prior to enrollment
- Documented or suspected hepatocellular carcinoma (HCC)
- Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy
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/ASV/BMS-791325Also: Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day | Drug | Arm 1, Arm 2, Arm 3 |
| DCV/ASV/BMS-791325 + RBVFixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day | Drug | Arm A, Arm B, Arm C |
Primary outcome
Sustained Virologic Response
Time frame: Post treatment week 12
Proportion of treated subjects in each enrolled arm with sustained virologic response (SVR)12. SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Week 12
7 secondary outcomes
Safety
Time frame: Up to end of treatment (+7 days)
Sustained virologic response
Time frame: 2, 4 and 24 weeks post-treatment
Post treatment virologic response
Time frame: post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24)
On treatment virologic response
Time frame: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12
Virologic failure
Time frame: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24
Day 2 positive predictive value
Time frame: Post treatment Week 12
Interferon lambda genotype and virologic response
Time frame: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24
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 19 Apr 2016.
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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.
Timothy R. Morgan, MD principal investigator
VA Long Beach Healthcare System/Southern California Institute for Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCV/ASV/BMS-791325 and DCV/ASV/BMS-791325 + RBV in people with Hepatitis C, run by Timothy Morgan, MD 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 3 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 19 Apr 2016. 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.
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?
Sustained Virologic Response (time frame: Post treatment week 12). 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 19 Apr 2016.