Chronic Hepatitis C InfectionPhase 2/3NCT02473211
SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients
A Phase 2/3 study testing Sofosbuvir and Daclatasvir in people with Chronic Hepatitis C Infection, run by Humanity and Health Research Centre at 2 sites in China.
Trial summary
For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex… 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2015to 15 Mar 2018
- Phase
- Phase 2/3
- 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
- Patients chronically infected with HCV Genotype-1b;
- Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin;
- HCV RNA level greater than 10,000 IU/ml at screening;
- Patients with compensated cirrhosis are permitted.
Who cannot join
- Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded;
- Screening ECG with clinically significant abnormalities;
- Laboratory results outside of acceptable ranges at screening;
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
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 of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection
For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.
Read the detailed description
Chinese genotype 1b HCV treatment-experienced cirrhotic patients are recruited and treated with 12 weeks sofosbuvir 400 mg daily plus daclatasvir 60 mg daily. At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined. Serial measurement of plasma HCV RNA levels are performed with the use of the COBAS TaqMan real-time assay (Roche version 2.0), at baseline, Day 2,4 and 7, week 2,4 and 12, post-treatment week 12. The primary efficacy end point is a sustained virologic response 12 weeks after the end of treatment (SVR12).
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- Sofosbuvir, Daclatasvir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofosbuvirDrug
Also called GS-7977
Sofosbuvir 400 mg tablet administered once daily
DaclatasvirDrug
Also called BMS-790052
Daclatasvir 60mg tablet administered once daily
| Study group | Role | What they receive |
|---|---|---|
| SOF+DCV | Experimental | Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks. Receives: Drug: Sofosbuvir; Drug: Daclatasvir |
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 the end of treatment (SVR12)
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug
Measured: Post treatment Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 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
- NCT02473211
- Sponsor's protocol ID
- H&H_SOF plus DCV treatment
- Status last verified
- Mar 2018
- First submitted
- 12 Jun 2015
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
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 of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection
- ClinicalTrials.gov ID
- NCT02473211
- Acronym / sponsor ID
- H&H_SOF plus DCV treatment
- Conditions
- Chronic Hepatitis C Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 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
- 16 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.
For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.
Detailed description
Chinese genotype 1b HCV treatment-experienced cirrhotic patients are recruited and treated with 12 weeks sofosbuvir 400 mg daily plus daclatasvir 60 mg daily. At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined. Serial measurement of plasma HCV RNA levels are performed with the use of the COBAS TaqMan real-time assay (Roche version 2.0), at baseline, Day 2,4 and 7, week 2,4 and 12, post-treatment week 12. The primary efficacy end point is a sustained virologic response 12 weeks after the end of treatment (SVR12).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOF+DCV | Experimental | Drug: Sofosbuvir, Drug: DaclatasvirParticipants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg 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 (4 listed)
- Patients chronically infected with HCV Genotype-1b;
- Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin;
- HCV RNA level greater than 10,000 IU/ml at screening;
- Patients with compensated cirrhosis are permitted.
Key exclusion criteria (4 listed)
- Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded;
- Screening ECG with clinically significant abnormalities;
- Laboratory results outside of acceptable ranges at screening;
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
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 |
|---|---|---|
| SofosbuvirAlso: GS-7977Sofosbuvir 400 mg tablet administered once daily | Drug | SOF+DCV |
| DaclatasvirAlso: BMS-790052Daclatasvir 60mg tablet administered once daily | Drug | SOF+DCV |
Primary outcome
Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12)
Time frame: Post treatment Week 12
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug
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 2/3 study testing Sofosbuvir and Daclatasvir 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 4 inclusion and 4 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 after the end of treatment (SVR12) (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 Mar 2018.