Chronic Hepatitis C InfectionPhase 4NCT02482077
Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients
A Phase 4 study testing SOF+RBV, SOF+DCV and LDV/SOF in people with Chronic Hepatitis C Infection, run by Humanity and Health Research Centre at 2 sites in China.
Trial summary
The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C Infection
- What is being tested?
- SOF+RBV, SOF+DCV and LDV/SOF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2015to 15 Mar 2018
- 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
- Age equal to or greater than 18 years, with chronic genotype 2 HCV infection;
- Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
- HCV RNA > 10,000 IU/mL at Screening;
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Who cannot join
- Pregnant or nursing female or male with pregnant female partner;
- HIV or chronic hepatitis B virus (HBV) infection;
- Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
- Active or recent history (≤ 1 year) of drug or alcohol abuse;
- Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Beijing, Beijing Municipality, 100039
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, 00852
About this study
Official title: Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 2 Infection
The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection.
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- SOF+RBV, SOF+DCV, LDV/SOF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOF+RBVDrug
Also called GS-7977, PSI-7977, Sovaldi®, Copegus®
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
SOF+DCVDrug
Also called GS-7977, PSI-7977, Sovaldi®, BMS-790052
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
LDV/SOFDrug
Also called GS-7977/GS-5885, Harvoni®
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| SOF+RBV 8 wk | Experimental | Participants will receive SOF+RBV for 8 weeks. Receives: Drug: SOF+RBV |
| SOF+RBV 12 wk | Experimental | Participants will receive SOF+RBV for 12 weeks. Receives: Drug: SOF+RBV |
| SOF+DCV 8 wk | Experimental | Participants will receive SOF+DCV for 8 weeks. Receives: Drug: SOF+DCV |
| SOF+DCV 12 wk | Experimental | Participants will receive SOF+DCV for 12 weeks. Receives: Drug: SOF+DCV |
| LDV/SOF 8 wk | Experimental | Participants will receive LDV/SOF for 8 weeks. Receives: Drug: LDV/SOF |
| LDV/SOF 12 wk | Experimental | Participants will receive LDV/SOF for 12 weeks. Receives: Drug: LDV/SOF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Measured: Post treatment Week 12
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Measured: Baseline up to Week 24
Secondary outcomes (3)
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
Measured: Baseline up to Week 24
HCV RNA levels and change during and after treatment.
Measured: Baseline up to Week 24
Proportion of participants with on-treatment virologic breakthrough and relapse
Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.
Measured: Baseline up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJan 2015
- Primary completion31 Dec 2017
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanity and Health Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital
- Responsible party
- Sponsor
- Investigators
- George KK Lau, MD, Principal investigator, Humanity and Health GI and Liver Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482077
- Sponsor's protocol ID
- H&H_HCV G2 Study
- Status last verified
- Mar 2018
- First submitted
- 23 Jun 2015
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 2 Infection
- ClinicalTrials.gov ID
- NCT02482077
- Acronym / sponsor ID
- H&H_HCV G2 Study
- Conditions
- Chronic Hepatitis C Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Humanity and Health Research CentreUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital
- Study start
- Jan 2015
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 25 Jun 2015 (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 assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SOF+RBV 8 wk | Experimental | Drug: SOF+RBVParticipants will receive SOF+RBV for 8 weeks. |
| SOF+RBV 12 wk | Experimental | Drug: SOF+RBVParticipants will receive SOF+RBV for 12 weeks. |
| SOF+DCV 8 wk | Experimental | Drug: SOF+DCVParticipants will receive SOF+DCV for 8 weeks. |
| SOF+DCV 12 wk | Experimental | Drug: SOF+DCVParticipants will receive SOF+DCV for 12 weeks. |
| LDV/SOF 8 wk | Experimental | Drug: LDV/SOFParticipants will receive LDV/SOF for 8 weeks. |
| LDV/SOF 12 wk | Experimental | Drug: LDV/SOFParticipants will receive LDV/SOF for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal to or greater than 18 years, with chronic genotype 2 HCV infection;
- Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
- HCV RNA > 10,000 IU/mL at Screening;
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Key exclusion criteria (5 listed)
- Pregnant or nursing female or male with pregnant female partner;
- HIV or chronic hepatitis B virus (HBV) infection;
- Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
- Active or recent history (≤ 1 year) of drug or alcohol abuse;
- Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).
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 |
|---|---|---|
| SOF+RBVAlso: GS-7977, PSI-7977, Sovaldi®, Copegus®Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). | Drug | SOF+RBV 12 wk, SOF+RBV 8 wk |
| SOF+DCVAlso: GS-7977, PSI-7977, Sovaldi®, BMS-790052Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily. | Drug | SOF+DCV 12 wk, SOF+DCV 8 wk |
| LDV/SOFAlso: GS-7977/GS-5885, Harvoni®Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily | Drug | LDV/SOF 12 wk, LDV/SOF 8 wk |
Primary outcome
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy
Time frame: Post treatment Week 12
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Time frame: Baseline up to Week 24
3 secondary outcomes
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
Time frame: Baseline up to Week 24
HCV RNA levels and change during and after treatment.
Time frame: Baseline up to Week 24
Proportion of participants with on-treatment virologic breakthrough and relapse
Time frame: Baseline up to Week 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 Mar 2018.
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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.
George KK Lau, MD principal investigator
Humanity and Health GI and Liver Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SOF+RBV, SOF+DCV and LDV/SOF in people with Chronic Hepatitis C Infection, run by Humanity and Health Research Centre at 2 sites in China.
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 5 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (time frame: Post treatment Week 12). The study lists 2 primary outcomes in all. 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 Mar 2018.