Chronic Hepatitis C InfectionPhase 2SWITCH-1NCT02583685
Switching Regimen in Treating Cirrhotic HCV GT1b Subjects
A Phase 2 study testing PR4 + LDV/SOF + ASV 4 wk, PR4 + LDV/SOF + SMV 4 wk and PR4 + LDV/SOF + ASV 6 wk in people with Chronic Hepatitis C Infection, run by Humanity and Health Research Centre at 2 sites in China.
Trial summary
This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C Infection
- What is being tested?
- PR4 + LDV/SOF + ASV 4 wk, PR4 + LDV/SOF + SMV 4 wk and PR4 + LDV/SOF + ASV 6 wk
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesChina
- Study dates
- 15 May 2015to 31 Oct 2024
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with chronic HCV GT1b infection;
- HCV RNA ≥ 10000 IU/mL at screening;
- Received 4 weeks pegylated interferon plus ribavirin (PR4) therapy and are intolerant to PR4;
- Cirrhosis determination; a liver biopsy may be required;
- Use of highly 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 HBV co-infection;
- Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
- Active or recent history (≤ 1 year) of drug or alcohol abuse;
- 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 Switching From Pegylated Interferon/Ribavirin (PR) to Direct-acting Antiviral Agents (DAAs) for Chinese With CHC Genotype 1b Infection (SWITCH-1)
This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- PR4 + LDV/SOF + ASV 4 wk, PR4 + LDV/SOF + SMV 4 wk, PR4 + LDV/SOF + ASV 6 wk, PR4 + LDV/SOF + SMV 6 wk, PR4 + LDV/SOF + ASV 8 wk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PR4 + LDV/SOF + ASV 4 wkDrug
Also called Pegasys®, Copegus®, Harvoni®, Sunvepra®
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
PR4 + LDV/SOF + SMV 4 wkDrug
Also called Pegasys®, Copegus®, Harvoni®, OLYSIO®
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
PR4 + LDV/SOF + ASV 6 wkDrug
Also called Pegasys®, Copegus®, Harvoni®, Sunvepra®
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
PR4 + LDV/SOF + SMV 6 wkDrug
Also called Pegasys®, Copegus®, Harvoni®, OLYSIO®
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
PR4 + LDV/SOF + ASV 8 wkDrug
Also called Pegasys®, Copegus®, Harvoni®, Sunvepra®
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
PR4 + LDV/SOF + SMV 8 wkDrug
Also called Pegasys®, Copegus®, Harvoni®, OLYSIO®
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
PR4 + LDV/SOF + ASV 12 wkDrug
Also called Pegasys®, Copegus®, Harvoni®, Sunvepra®
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
PR4 + LDV/SOF + SMV 12 wkDrug
Also called Pegasys®, Copegus®, Harvoni®, OLYSIO®
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| PR4 + LDV/SOF + ASV 4 wk | Experimental | Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 2 will receive LDV/SOF + ASV for 4 weeks. Receives: Drug: PR4 + LDV/SOF + ASV 4 wk |
| PR4 + LDV/SOF + SMV 4 wk | Experimental | Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 2 will receive LDV/SOF + SMV for 4 weeks. Receives: Drug: PR4 + LDV/SOF + SMV 4 wk |
| PR4 + LDV/SOF + ASV 6 wk | Experimental | Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 4 will receive LDV/SOF + ASV for 6 weeks. Receives: Drug: PR4 + LDV/SOF + ASV 6 wk |
| PR4 + LDV/SOF + SMV 6 wk | Experimental | Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 4 will receive LDV/SOF + SMV for 6 weeks. Receives: Drug: PR4 + LDV/SOF + SMV 6 wk |
| PR4 + LDV/SOF + ASV 8 wk | Experimental | Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA > 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + ASV for 8 weeks. Receives: Drug: PR4 + LDV/SOF + ASV 8 wk |
| PR4 + LDV/SOF + SMV 8 wk | Experimental | Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA > 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + SMV for 8 weeks. Receives: Drug: PR4 + LDV/SOF + SMV 8 wk |
| PR4 + LDV/SOF + ASV 12 wk | Experimental | Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <2 log drop by week 4 will receive LDV/SOF + ASV for 12 weeks. Receives: Drug: PR4 + LDV/SOF + ASV 12 wk |
| PR4 + LDV/SOF + SMV 12 wk | Experimental | Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <2 log drop by week 4 will receive LDV/SOF + SMV for 12 weeks. Receives: Drug: PR4 + LDV/SOF + SMV 12 wk |
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 < 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 (5)
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
Measured: Baseline up to Week 24
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 evaluated with questionnaires
To evaluate the change in health-related quality of life during and after treatment with questionnaires
Measured: Up to Posttreatment Week 24
Change in mental health evaluated with questionnaires
To evaluate the change in mental health during and after treatment with questionnaires
Measured: Up to Posttreatment Week 24
Liver disease progression
Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start15 May 2015
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanity and Health Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital, Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
- Investigators
- George Lau, Principal investigator, Humanity and Health GI and Liver Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583685
- Sponsor's protocol ID
- H&H_SWITCH-1
- Acronym
- SWITCH-1
- Status last verified
- Mar 2025
- First submitted
- 12 Oct 2015
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Switching From Pegylated Interferon/Ribavirin (PR) to Direct-acting Antiviral Agents (DAAs) for Chinese With CHC Genotype 1b Infection (SWITCH-1)
- ClinicalTrials.gov ID
- NCT02583685
- Acronym / sponsor ID
- SWITCH-1 / H&H_SWITCH-1
- Conditions
- Chronic Hepatitis C Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Humanity and Health Research CentreUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital, Nanfang Hospital, Southern Medical University
- Study start
- 15 May 2015 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 22 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.
This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| PR4 + LDV/SOF + ASV 4 wk | Experimental | Drug: PR4 + LDV/SOF + ASV 4 wkParticipants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 2 will receive LDV/SOF + ASV for 4 weeks. |
| PR4 + LDV/SOF + SMV 4 wk | Experimental | Drug: PR4 + LDV/SOF + SMV 4 wkParticipants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 2 will receive LDV/SOF + SMV for 4 weeks. |
| PR4 + LDV/SOF + ASV 6 wk | Experimental | Drug: PR4 + LDV/SOF + ASV 6 wkParticipants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 4 will receive LDV/SOF + ASV for 6 weeks. |
| PR4 + LDV/SOF + SMV 6 wk | Experimental | Drug: PR4 + LDV/SOF + SMV 6 wkParticipants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 4 will receive LDV/SOF + SMV for 6 weeks. |
| PR4 + LDV/SOF + ASV 8 wk | Experimental | Drug: PR4 + LDV/SOF + ASV 8 wkParticipants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA > 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + ASV for 8 weeks. |
| PR4 + LDV/SOF + SMV 8 wk | Experimental | Drug: PR4 + LDV/SOF + SMV 8 wkParticipants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA > 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + SMV for 8 weeks. |
| PR4 + LDV/SOF + ASV 12 wk | Experimental | Drug: PR4 + LDV/SOF + ASV 12 wkParticipants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <2 log drop by week 4 will receive LDV/SOF + ASV for 12 weeks. |
| PR4 + LDV/SOF + SMV 12 wk | Experimental | Drug: PR4 + LDV/SOF + SMV 12 wkParticipants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <2 log drop by week 4 will receive LDV/SOF + SMV for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals with chronic HCV GT1b infection;
- HCV RNA ≥ 10000 IU/mL at screening;
- Received 4 weeks pegylated interferon plus ribavirin (PR4) therapy and are intolerant to PR4;
- Cirrhosis determination; a liver biopsy may be required;
- Use of highly 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 HBV co-infection;
- Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
- Active or recent history (≤ 1 year) of drug or alcohol abuse;
- 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.
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 |
|---|---|---|
| PR4 + LDV/SOF + ASV 4 wkAlso: Pegasys®, Copegus®, Harvoni®, Sunvepra®Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily. | Drug | PR4 + LDV/SOF + ASV 4 wk |
| PR4 + LDV/SOF + SMV 4 wkAlso: Pegasys®, Copegus®, Harvoni®, OLYSIO®Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily. | Drug | PR4 + LDV/SOF + SMV 4 wk |
| PR4 + LDV/SOF + ASV 6 wkAlso: Pegasys®, Copegus®, Harvoni®, Sunvepra®Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily. | Drug | PR4 + LDV/SOF + ASV 6 wk |
| PR4 + LDV/SOF + SMV 6 wkAlso: Pegasys®, Copegus®, Harvoni®, OLYSIO®Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily. | Drug | PR4 + LDV/SOF + SMV 6 wk |
| PR4 + LDV/SOF + ASV 8 wkAlso: Pegasys®, Copegus®, Harvoni®, Sunvepra®Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily. | Drug | PR4 + LDV/SOF + ASV 8 wk |
| PR4 + LDV/SOF + SMV 8 wkAlso: Pegasys®, Copegus®, Harvoni®, OLYSIO®Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily. | Drug | PR4 + LDV/SOF + SMV 8 wk |
| PR4 + LDV/SOF + ASV 12 wkAlso: Pegasys®, Copegus®, Harvoni®, Sunvepra®Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily. | Drug | PR4 + LDV/SOF + ASV 12 wk |
| PR4 + LDV/SOF + SMV 12 wkAlso: Pegasys®, Copegus®, Harvoni®, OLYSIO®Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily. | Drug | PR4 + LDV/SOF + SMV 12 wk |
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 < 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
5 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
Treatment adherence
Time frame: Baseline to Week 12
Change in health related quality of life evaluated with questionnaires
Time frame: Up to Posttreatment Week 24
Change in mental health evaluated with questionnaires
Time frame: Up to Posttreatment Week 24
Liver disease progression
Time frame: Up to 10 years
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 26 Mar 2025.
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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 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 study testing PR4 + LDV/SOF + ASV 4 wk, PR4 + LDV/SOF + SMV 4 wk and PR4 + LDV/SOF + ASV 6 wk 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 26 Mar 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Mar 2025.