Chronic Hepatitis C InfectionPhase 4NCT02480686
Neutrino Regimen for Treatment-experienced HCV GT1 Patients
A Phase 4 study testing SOF+PEG+RBV in people with Chronic Hepatitis C Infection, run by Humanity and Health Research Centre at 2 sites in China.
Trial summary
This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Hepatitis C Infection
- What is being tested?
- SOF+PEG+RBV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2015to Aug 2016
- 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 to 80 years
- 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 1b infection;
- HCV RNA equal to or greater than 10,000 IU/mL at Screening;
- Cirrhosis determination;
- Subjects who are treatment-experienced;
- Screening laboratory values within defined thresholds;
- Use of highly effective contraception methods if female of childbearing potential or sexually active male.
Who cannot join
- HIV or chronic hepatitis B virus (HBV) infection;
- Contraindications for PEG or RBV therapy;
- 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);
- Chronic use of systemic immunosuppressive agents;
- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
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 Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients
This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- SOF+PEG+RBV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOF+PEG+RBVDrug
Also called GS-7977, PSI-7977, Sovaldi®, Pegasys®
Sofosbuvir (SOF) 400 mg tablet is administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection; Ribavirin (RBV) was administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
| Study group | Role | What they receive |
|---|---|---|
| SOF+PEG+RBV | Experimental | Participants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks. Receives: Drug: SOF+PEG+RBV |
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)
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)
Adverse events leading to permanent discontinuation of study drug(s)
Measured: Baseline up to Week 24
Secondary outcomes (2)
Change in HCV RNA From Baseline to Week 12
Measured: Baseline up to Week 24
Proportion of participants with on-treatment virologic breakthrough and relapse
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 posted24 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionAug 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 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 CentreGuofeng Chen, MD, Principal investigator, 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480686
- Sponsor's protocol ID
- H&H_Neutrino Therapy
- Status last verified
- Aug 2016
- First submitted
- 21 Jun 2015
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients
- ClinicalTrials.gov ID
- NCT02480686
- Acronym / sponsor ID
- H&H_Neutrino Therapy
- Conditions
- Chronic Hepatitis C Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Humanity and Health Research CentreUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 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.
This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOF+PEG+RBV | Experimental | Drug: SOF+PEG+RBVParticipants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- 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 1b infection;
- HCV RNA equal to or greater than 10,000 IU/mL at Screening;
- Cirrhosis determination;
- Subjects who are treatment-experienced;
- Screening laboratory values within defined thresholds;
Key exclusion criteria (7 listed)
- HIV or chronic hepatitis B virus (HBV) infection;
- Contraindications for PEG or RBV therapy;
- 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+PEG+RBVAlso: GS-7977, PSI-7977, Sovaldi®, Pegasys®Sofosbuvir (SOF) 400 mg tablet is administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection; Ribavirin (RBV) was administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). | Drug | SOF+PEG+RBV |
Primary outcome
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
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
Adverse events leading to permanent discontinuation of study drug(s)
2 secondary outcomes
Change in HCV RNA From Baseline to Week 12
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 22 Aug 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.
George Lau, MD principal investigator
Humanity and Health GI and Liver Centre
Guofeng Chen, MD principal investigator
302 Hospital
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+PEG+RBV 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 7 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 22 Aug 2016. 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 (SVR12) (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 22 Aug 2016.