Hepatitis CPhase 4DARE-C IINCT02156570
DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral)
A Phase 4 study testing Sofosbuvir and ribavirin in people with Hepatitis C, run by Kirby Institute at 5 sites in 2 countries.
Trial summary
The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C… 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?
- Sofosbuvir and ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2014to Dec 2017
- Phase
- Phase 4
- 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
- Provision of written informed consent
- Male and female patients aged 18 years and above
- Willing to use two effective methods of contraception during the treatment period and 24 weeks post.
- HBsAg negative
- Detectable HCV RNA at screening (>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
- Compensated liver disease (Child-Pugh A)
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- Negative pregnancy test at screening and 24 hours prior to first dose of study drugs
- Medically stable on the basis of physical examination, medical history and vital signs
- Adequate English to provide reliable responses to the study questionnaires
- Recent hepatitis C infection, as defined by: A) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV Ab negative within the 24 months prior to anti-HCV antibody positive result, OR B) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the previous 12 months prior to first positive HCV antibody or HCV RNA, with no other cause of acute hepatitis identifiable
- If co-infection with HIV is documented, the subject must meet the following criteria:
- Antiretroviral (ARV) untreated for >8 weeks preceding screening visit with CD4 T cell count >500 cells/mm3 OR
- On a stable ARV regimen for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and an undetectable plasma HIV RNA level.
Who cannot join
- Standard exclusions to RBV therapy
- Pregnancy/lactation or male subjects whose female partners are pregnant
- Subject has a history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding oesophageal varices, and/or any of the following screening laboratory results: a.INR of ≥1.5; Serum albumin <3.3 g/dL; Serum total bilirubin >1.8 times upper limit of normal, unless isolated in subjects with Gilbert's syndrome.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Melbourne, Victoria, 3050
St Vincent's Hospital
Sydney, New South Wales, 2010
About this study
Official title: An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection
The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment.
The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.
Read the detailed description
To evaluate the efficacy, safety and acceptability of an interferon-sparing strategy with sofosbuvir and ribavirin for the treatment of recently acquired HCV infection.
An open label single arm multicentre study Treatment of participants: Sofosbuvir 400mg daily with weight based ribavirin (1000mg <75 kg, 1200mg >/= 75kg) Duration of treatment will be 6 weeks for all subjects followed by 52 weeks of observational follow-up Total study duration = 58 weeks Primary endpoint: SVR 12
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir and ribavirin
- Keywords
- Hepatitis C, Acute/early chronic, Recently acquired, Directly acting antiviral therapy, Sofosbuvir, Ribavirin
- Medical subject headings
- Hepatitis C, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir and ribavirinDrug
Also called Sovaldi, Copegus
Sofosbuvir 400mg daily plus weight-based dosing ribavirin (1000mg <75kg, 1200mg >/= 75 kg) Treatment will be for 6 weeks in all participants.
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir and ribavirin | Experimental | Sofosbuvir tablet 400 mg daily Ribavirin tablet weight based dosing (1000mg <75 kg, 1200mg >/= 75kg) daily
Treatment will be for 6 weeks in all participants. Receives: Drug: Sofosbuvir and ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR 12
Proportion of patients with undetectable HCV RNA by TaqMan 12 weeks after therapy completion (SVR 12 - Week 18)
Measured: 12 weeks post treatment
Secondary outcomes (1)
SVR 24
Proportion of patients with undetectable HCV RNA by TaqMan 24 weeks after therapy completion (SVR 24 - Week 30)
Measured: 24 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2017
- Study completionDec 2017
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gail Matthews, MbChB FRACP, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156570
- Sponsor's protocol ID
- VHCRP1206
- Acronym
- DARE-C II
- Status last verified
- Sep 2018
- First submitted
- 3 Jun 2014
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT02156570
- Acronym / sponsor ID
- DARE-C II / VHCRP1206
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Acute/early chronic, Recently acquired, Directly acting antiviral therapy, Sofosbuvir, Ribavirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Oct 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Jun 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 the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment.
The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.
Detailed description
To evaluate the efficacy, safety and acceptability of an interferon-sparing strategy with sofosbuvir and ribavirin for the treatment of recently acquired HCV infection.
An open label single arm multicentre study Treatment of participants: Sofosbuvir 400mg daily with weight based ribavirin (1000mg <75 kg, 1200mg >/= 75kg) Duration of treatment will be 6 weeks for all subjects followed by 52 weeks of observational follow-up Total study duration = 58 weeks Primary endpoint: SVR 12
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir and ribavirin | Experimental | Drug: Sofosbuvir and ribavirinSofosbuvir tablet 400 mg daily Ribavirin tablet weight based dosing (1000mg <75 kg, 1200mg >/= 75kg) daily Treatment will be for 6 weeks in all participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Provision of written informed consent
- Male and female patients aged 18 years and above
- Willing to use two effective methods of contraception during the treatment period and 24 weeks post.
- HBsAg negative
- Detectable HCV RNA at screening (>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
Key exclusion criteria (3 listed)
- Standard exclusions to RBV therapy
- Pregnancy/lactation or male subjects whose female partners are pregnant
- Subject has a history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding oesophageal varices, and/or any of the following screening laboratory results: a.INR of ≥1.5; Serum albumin <3.3 g/dL; Serum total bilirubin >1.8 times upper limit of normal, unless isolated in subjects with Gilbert's syndrome.
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 |
|---|---|---|
| Sofosbuvir and ribavirinAlso: Sovaldi, CopegusSofosbuvir 400mg daily plus weight-based dosing ribavirin (1000mg <75kg, 1200mg >/= 75 kg) Treatment will be for 6 weeks in all participants. | Drug | Sofosbuvir and ribavirin |
Primary outcome
SVR 12
Time frame: 12 weeks post treatment
Proportion of patients with undetectable HCV RNA by TaqMan 12 weeks after therapy completion (SVR 12 - Week 18)
1 secondary outcome
SVR 24
Time frame: 24 weeks post treatment
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 21 Sep 2018.
- UNSW Kirby Institute for infection and immunity in society HomepageLink provided by the sponsor.
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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.
Gail Matthews, MbChB FRACP principal investigator
Kirby Institute
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir and ribavirin in people with Hepatitis C, run by Kirby Institute at 5 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 13 inclusion and 3 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 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, New Zealand. 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?
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?
SVR 12 (time frame: 12 weeks post treatment). 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 21 Sep 2018.