A Phase 2 interventional study of PR4 + LDV/SOF + ASV 4 wk and PR4 + LDV/SOF + SMV 4 wk in Chronic Hepatitis C Infection, sponsored by Humanity and Health Research Centre. Completed at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Humanity and Health Research Centre · Phase 2, Interventional, and Treatment
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.
950 studies on the registry are indexed under Hepatitis C, Chronic; 8 are open to participants now.
This study's enrollment of 138 is above the median of 90 across 696 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →Humanity and Health Research Centre is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: PR4 + LDV/SOF + ASV 4 wk
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.
Drug: PR4 + LDV/SOF + SMV 4 wk
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.
Drug: PR4 + LDV/SOF + ASV 6 wk
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.
Drug: PR4 + LDV/SOF + SMV 6 wk
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.
Drug: PR4 + LDV/SOF + ASV 8 wk
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.
Drug: PR4 + LDV/SOF + SMV 8 wk
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.
Drug: PR4 + LDV/SOF + ASV 12 wk
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.
Drug: PR4 + LDV/SOF + SMV 12 wk
Drug page: Peginterferon alfa-2a
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.
Also known as: Pegasys®, Copegus®, Harvoni®, Sunvepra®
Drug page: Peginterferon alfa-2a
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.
Also known as: Pegasys®, Copegus®, Harvoni®, OLYSIO®
Drug page: Peginterferon alfa-2a
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.
Also known as: Pegasys®, Copegus®, Harvoni®, Sunvepra®
Drug page: Peginterferon alfa-2a
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.
Also known as: Pegasys®, Copegus®, Harvoni®, OLYSIO®
Drug page: Peginterferon alfa-2a
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.
Also known as: Pegasys®, Copegus®, Harvoni®, Sunvepra®
Drug page: Peginterferon alfa-2a
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.
Also known as: Pegasys®, Copegus®, Harvoni®, OLYSIO®
Drug page: Peginterferon alfa-2a
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.
Also known as: Pegasys®, Copegus®, Harvoni®, Sunvepra®
Drug page: Peginterferon alfa-2a
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.
Also known as: Pegasys®, Copegus®, Harvoni®, OLYSIO®
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.
Time frame: Post treatment Week 12
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Time frame: Baseline up to Week 24
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
To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Up to 10 years
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Peginterferon alfa-2a
Humanity and Health Research Centre