Chronic Hepatitis C InfectionPhase 3NCT02576314
Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients
A Phase 3 study testing sofosbuvir and daclatasvir and ledipasvir/sofosbuvir 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 genotype 3 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?
- sofosbuvir and daclatasvir and ledipasvir/sofosbuvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- May 2015to 15 Mar 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 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 3 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;
- Negative pregnancy test at baseline (females of childbearing potential only);
- Use of two effective contraception methods if female of childbearing potential or sexually active male.
Who cannot join
- Pregnant or nursing female;
- HIV infection or HBV infection (HBcAb and HBsAg positive);
- 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 3 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 genotype 3 infection.
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- sofosbuvir and daclatasvir, ledipasvir/sofosbuvir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvir and daclatasvirDrug
Also called Sovaldi®, PSI-7977, GS-7977, Daklinza®
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.
ledipasvir/sofosbuvirDrug
Also called Harvoni®, GS-5885, GS-7977, PSI-7977
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally.
once daily;
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir and Daclatasvir | Active comparator | Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks. Receives: Drug: sofosbuvir and daclatasvir |
| Ledipasvir/sofosbuvir | Active comparator | Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks. Receives: Drug: ledipasvir/sofosbuvir |
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 (SVR12) after discontinuation of therapy
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication
Measured: Post treatment Week 12
Incidence of adverse events leading to permanent discontinuation of study drug
Measured: Baseline up to Week 12
Secondary outcomes (4)
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
Measured: Baseline up to Week 12
HCV RNA levels and change during and after treatment
Measured: Baseline up to Week 12
Treatment adherence
To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)
Measured: Baseline to Week 12
Change in health related quality of life
To evaluate the change in health-related quality of life during treatment
Measured: Baseline 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 posted15 Oct 2015 (estimated)
- Study startMay 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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 Lau, MD, Principal investigator, Humanity and Health GI and Liver Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576314
- Sponsor's protocol ID
- H&H_HCV G3 Study
- Status last verified
- Mar 2018
- First submitted
- 12 Oct 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 3 Infection
- ClinicalTrials.gov ID
- NCT02576314
- Acronym / sponsor ID
- H&H_HCV G3 Study
- Conditions
- Chronic Hepatitis C Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Humanity and Health Research CentreUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital
- Study start
- May 2015
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 15 Oct 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 genotype 3 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir and Daclatasvir | Active comparator | Drug: sofosbuvir and daclatasvirParticipants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks. |
| Ledipasvir/sofosbuvir | Active comparator | Drug: ledipasvir/sofosbuvirParticipants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily 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 (6 listed)
- Age equal to or greater than 18 years, with chronic genotype 3 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;
- Negative pregnancy test at baseline (females of childbearing potential only);
Key exclusion criteria (5 listed)
- Pregnant or nursing female;
- HIV infection or HBV infection (HBcAb and HBsAg positive);
- 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 |
|---|---|---|
| sofosbuvir and daclatasvirAlso: Sovaldi®, PSI-7977, GS-7977, Daklinza®Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily. | Drug | Sofosbuvir and Daclatasvir |
| ledipasvir/sofosbuvirAlso: Harvoni®, GS-5885, GS-7977, PSI-7977Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally. once daily; | Drug | Ledipasvir/sofosbuvir |
Primary outcome
Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy
Time frame: Post treatment Week 12
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication
Incidence of adverse events leading to permanent discontinuation of study drug
Time frame: Baseline up to Week 12
4 secondary outcomes
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
Time frame: Baseline up to Week 12
HCV RNA levels and change during and after treatment
Time frame: Baseline up to Week 12
Treatment adherence
Time frame: Baseline to Week 12
Change in health related quality of life
Time frame: Baseline 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 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 3 study testing sofosbuvir and daclatasvir and ledipasvir/sofosbuvir 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 6 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 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?
Proportion of participants with sustained virologic response 12 weeks (SVR12) 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.