A Phase 4 interventional study of Sofosbuvir and Velpatasvir and Ribavirin in Hepatitis C Virus Infection, Response to Therapy of and Human Immunodeficiency Virus, sponsored by National Taiwan University Hospital. Completed at 2 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment
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Among 174 studies testing ribavirin in Hepatitis C — none open to participants now, 1 under way, none of them phase 3. Ribavirin · Hepatitis C.
Among the 174 studies testing ribavirin in Hepatitis C, this one is the 36th largest by enrollment, is one of 14 that started in 2016, is one of 44 in phase 4, and was the 171st registered.
1,744 studies on the registry are indexed under Hepatitis C; 98 are open to participants now.
Browse Hepatitis C studies →None of the 174 studies testing ribavirin in Hepatitis C is open now. The open studies under Hepatitis C, anywhere →
Ribavirin: first FDA approval 1985 (VIRAZOLE), first EMA approval 1999. What it is approved for, and how studies give it, is on its page →
Of the 56 Hepatitis C studies recruiting now, 43 (77%) set no upper age limit and 6 (11%) stop at 75 or younger; 10 take children under 18; 26 take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
174 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 61 · Phase 3 64 · Phase 4 44
First in 1997; this study’s year is marked. 14 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 228 is above the median of 73 across 1,224 interventional studies indexed under Hepatitis C.
Median enrollment 78 across the 174 interventional studies. Of the 158 that completed or were terminated, 79 (50%) have results posted.
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84 of 174 have an industry lead sponsor. The 10 most frequent:
National Taiwan University Hospital is the lead sponsor of 2,617 studies on the registry; 578 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
21 studies in Hepatitis C by National Taiwan University Hospital: 1 open now, 2 under way, none of them phase 3. Of 9 finished, 2 (22%) have results posted.
Among the 21 studies in Hepatitis C by National Taiwan University Hospital, this one is the 4th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2016, is one of 5 in phase 4, and was the 11th registered.
National Taiwan University Hospital’s Hepatitis C studies by the year they started, since 2004.
None of the studies under way reaches primary completion within a year.
Among the 174 studies testing ribavirin in Hepatitis C, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among National Taiwan University Hospital’s 21 in Hepatitis C:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) with or without ribavirin (RBV) for the treatment of hepatitis C virus (HCV) in patients with human immunodeficiency virus (HIV) coinfection. We aim to compare the effectiveness and safety of VEL/SOF with and without RBV for 12 weeks in HIV/HCV-coinfected and HCV-monoinfected patients The antiviral responses and the adverse events (AEs) are compare between the two groups. The characteristics potentially related to sustained virologic response 12 weeks off therapy (SVR12) are analyzed.
Due to the lack of effective vaccination and the shared routes of transmission, hepatitis C virus (HCV) infection remains a challenging co-morbidity in patients with human immunodeficiency virus (HIV) infection. It is estimated that approximately 2.3 million people are coinfected with HIV and HCV (HIV/HCV) in the world. Compared to patients with HCV monoinfection, HIV/HCV-coinfected patients tend to have higher serum HCV viral loads, faster hepatic fibrosis progression, and higher risks of hepatic decompensation. Following the commencement of scale-up antiretroviral therapy (ART) that decreases the HIV-related opportunistic infections and malignancies, the liver-related complications have now become the leading cause of morbidity and mortality in HIV/HCV-coinfected patients. On the other hand, the survival rate is improved if these patients achieve sustained virologic response (SVR) by anti-HCV agents.
On the basis of excellent efficacy and safety, treatment by interferon (IFN)-free direct acting antiviral agents (DAAs) has made a paradigm shift for HCV care. Velpatasvir (VEL) is an HCV non-structural protein 5A (NS5A) inhibitor and sofosbuvir (SOF) is an HCV NS5B nucleotide polymerase inhibitor. Both agents are active against HCV with pan-genotypic potency. A fixed-dose combination of VEL at a daily dosage of 100 mg and SOF at a daily dosage of 400 mg (VEL/SOF) with or without weight-based ribavirin (RBV) has been approved by U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to treat HCV genotype 1-6 patients with compensated and decompensated liver diseases, respectively. Recently, a phase 3 study of VEL/SOF to treat HCV infection in HIV-coinfected patients reveals that this regimen is safe and provides a high and comparable SVR rate to HCV-monoinfected patients.
Although treatment of HCV by IFN-free DAAs is considered highly efficacious and well tolerated, numerous HCV-infected individuals have limited access to the brand-name agents due to the lack of universal governmental reimbursement or private insurance support. Therefore, allowing the generic version of patented DAAs for HCV through voluntary or compulsory licensing may provide patients with greater access to new HCV treatment, particularly in resource-constrained countries. Regarding the real-world experiences of generic IFN-free DAAs, a recent report from China evaluated the effectiveness of a generic version of ledipasvir (LDV) plus SOF (LDV/SOF) with or without RBV for 8-12 weeks in 192 HCV genotype 1b (HCV-1b) patients. The overall SVR rates were excellent (96.8%-96.9%) and most patients tolerated the treatment well. Based on the encouraging results, we aim to evaluate the effectiveness and safety of a generic version of pan-genotypic VEL/SOF-based therapy for HCV in HIV-coinfected patients, and compare the performance of such a regimen in HCV-monoinfected patients.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) received a generic version of Sofosbuvir and Velpatasvir fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.
Drug: Sofosbuvir and Velpatasvir
Patients with decompensated cirrhosis (Child-Pugh B or C) received Sofosvel® 1 tablet per day in combination with weight-based ribavirin (RBV)(Robatrol®, 200 mg capsule, Genovate Biotechnology Co. Ltd., Hsinchu, Taiwan; 1,200 mg per day if the body weight ≥ 75 kg; 1,000 mg per day if the body weight \< 75 mg) for 12 weeks.
Drug: Sofosbuvir and Velpatasvir · Drug: Ribavirin
Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) received a generic version of Sofosbuvir and Velpatasvir fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.
Drug: Sofosbuvir and Velpatasvir
Patients with decompensated cirrhosis (Child-Pugh B or C) received Sofosvel® 1 tablet per day in combination with weight-based ribavirin (RBV)(Robatrol®, 200 mg capsule, Genovate Biotechnology Co. Ltd., Hsinchu, Taiwan; 1,200 mg per day if the body weight ≥ 75 kg; 1,000 mg per day if the body weight \< 75 mg) for 12 weeks.
Drug: Sofosbuvir and Velpatasvir · Drug: Ribavirin
Drug pages: Sofosbuvir · Velpatasvir
All patients received a generic version of VEL/SOF fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.
Also known as: Sofosvel
Patients with decompensated cirrhosis (Child-Pugh B or C), received weight-based ribavirin (RBV)(Robatrol®, 200 mg capsule, Genovate Biotechnology Co. Ltd., Hsinchu, Taiwan; 1,200 mg per day if the body weight ≥ 75 kg; 1,000 mg per day if the body weight \< 75 mg) for 12 weeks.
Also known as: Robatrol
Sustained virologic response
HCV RNA \< LLOQ 12 weeks off therapy
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2016 to primary completion in Jul 2017, 11 months.
Of 56 non-industry phase 4 interventional studies under Hepatitis C, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 49. This study's 11 months is below that.
Counting every sponsor, half of 58 studies reached it within 24 months; a quarter within 16 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ribavirin
National Taiwan University Hospital →