A Phase 4 interventional study of Peginterferon alfa-2a and ribavirin and Peginterferon alfa-2a in Chronic Hepatitis C, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-02-10.
Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment
Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in immunocompetent patients. In dialysis patients, treatment with conventional or pegylated interferon has also received much attention recently. Two meta-analyses evaluating the efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic response (SVR) rates were 37% and 33%, respectively; and the corresponding dropout rates were 17% and 29.6%, respectively.The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis patients showed conflicting results, with a more favorable outcome of patients treated with pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated) than those treated with pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated. Currently, IFN-based therapy to treatment HCV infection should be initiated in dialysis stages, because the use of IFN in RT patients harbors high risks of acute graft rejection,and have low response rates under the concomitant use of immunosuppressive agents.
Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the general patients and achieve a higher SVR rate than IFN monotherapy, is considered contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of treatment. In addition, a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50%. In this study, treatment with pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with pegylated IFN alfa-2b plus low dose ribavirin (100% vs. 25%).
Based on the long-term favorable outcome in dialysis patients who eradicate HCV, and the superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b plus low dose ribavirin in treating dialysis patients with chronic hepatitis C, the aim of the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose ribavirin versus pegylated interferon alfa-2a alone in treatment naïve dialysis patients with chronic hepatitis C.
Chronic hepatitis C virus (HCV) infection is common in dialysis patients, with the reported prevalence varying from 3% to 80% worldwide. (1-3) Although these patients usually have mild symptoms and moderate elevation of alanine transaminase levels, recent international collaborative survey and prospective studies found that anti-HCV seropositivity and positive HCV RNA were risk factors for mortality and hepatocellular carcinoma (HCC). (4-7) Furthermore, progressive hepatic fibrosis, poor patient and graft survival were observer in dialysis patients with HCV infection who undergo renal transplantation (RT), suggesting immunosuppression following RT may worsen the course of hepatic fibrosis and renal graft function. (8-13) These lines of evidence indicate that HCV infection in the dialysis population is an important issue to be tackled.
Interferon (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in immunocompetent patients. In dialysis patients, treatment with conventional or pegylated interferon has also received much attention recently. Two meta-analyses evaluating the efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic response (SVR) rates were 37% and 33%, respectively; and the corresponding dropout rates were 17% and 29.6%, respectively.(14,15) The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis patients showed conflicting results, with a more favorable outcome of patients treated with pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated) than those treated with pegylated IFN alfa-2b (0.5-1.0 μg/week: SVR 12.5%, poorly tolerated), (16-21) which may result from different pharmacokinetic profiles between these two pegylated IFNs. Currently, IFN-based therapy to treatment HCV infection should be initiated in dialysis stages, because the use of IFN in RT patients harbors high risks of acute graft rejection,(22,23) and have low response rates under the concomitant use of immunosuppressive agents. (24,25) Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the general patients and achieve a higher SVR rate than IFN monotherapy, is considered contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of treatment. (26-28) In addition, a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50%. (29) In this study, treatment with pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with pegylated IFN alfa-2b plus low dose ribavirin (100% vs. 25%) Based on the long-term favorable outcome in dialysis patients who eradicate HCV, and the superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b plus low dose ribavirin in treating dialysis patients with chronic hepatitis C, the aim of the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose ribavirin versus pegylated interferon alfa-2a in treatment naïve dialysis patients with chronic hepatitis C.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 377 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Drug: Peginterferon alfa-2a and ribavirin
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Drug: Peginterferon alfa-2a
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Also known as: Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche), Ribavirin (Copegus, F. Hoffman-LaRoche)
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Also known as: Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche)
Sustained Virologic Response (SVR)Rate
Time frame: 1.5 year
Adverse Event (AE)-Related Withdrawal Rate
Time frame: 1.5 year
Recruitment from 1 June, 2007 to 9 May, 2012 Location: 8 academic centers in Taiwan
| Milestone | Peginterferon and Ribavirin | Peginterferon |
|---|---|---|
| Started | 189 | 188 |
| Completed | 162 | 168 |
| Not completed | 27 | 20 |
| participants | Peginterferon and Ribavirin | Peginterferon |
|---|---|---|
| Sustained Virologic Response (SVR)Rate | 130 | 72 |
| participants | Peginterferon and Ribavirin | Peginterferon |
|---|---|---|
| Advese event related withdrawal rate | 12 | 7 |
| Non withdrawal | 177 | 171 |
Collected over 18 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Peginterferon and Ribavirin | — | 8/189 (4.2%) | 170/189 (89.9%) |
| Peginterferon | — | 7/188 (3.7%) | 154/188 (81.9%) |
| Event | Peginterferon and Ribavirin | Peginterferon |
|---|---|---|
| PneumoniaInfections and infestations | 2/189 | 3/188 |
| Postural dizzinessCardiac disorders | 2/189 | 0/188 |
| CholangitisInfections and infestations | 0/189 | 1/188 |
| Major depressionPsychiatric disorders | 0/189 | 1/188 |
| Peptic ulcer bleedingGastrointestinal disorders | 0/189 | 1/188 |
| Salmonella gastroenteritisInfections and infestations | 0/189 | 1/188 |
| Intractable diarrheaGastrointestinal disorders | 1/189 | 0/188 |
| Hepatocellular carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/189 | 0/188 |
| PeritonitisInfections and infestations | 1/189 | 0/188 |
| Stevens-Johnson sybdromeSkin and subcutaneous tissue disorders | 1/189 | 0/188 |
| Event | Peginterferon and Ribavirin | Peginterferon |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 134/189 | 13/188 |
| FatigueNervous system disorders | 106/189 | 97/188 |
| InsomniaNervous system disorders | 62/189 | 66/188 |
| HeadacheNervous system disorders | 51/189 | 48/188 |
| Flu-like syndromeImmune system disorders | 47/189 | 50/188 |
| Hair lossSkin and subcutaneous tissue disorders | 47/189 | 43/188 |
| AnorexiaGastrointestinal disorders | 44/189 | 38/188 |
| DermatitisSkin and subcutaneous tissue disorders | 43/189 | 38/188 |
| NeutropeniaBlood and lymphatic system disorders | 30/189 | 26/188 |
| Injection site reactionSkin and subcutaneous tissue disorders | 27/189 | 27/188 |
| Age, Categorical(Participants) | Peginterferon and Ribavirin | Peginterferon | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 189 | 188 | 377 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Peginterferon and Ribavirin | Peginterferon | Total |
|---|---|---|---|
| Mean | 51 ± 10 | 51 ± 11 | 51 ± 10 |
| Sex: Female, Male(Participants) | Peginterferon and Ribavirin | Peginterferon | Total |
|---|---|---|---|
| Female | 76 | 76 | 152 |
| Male | 113 | 112 | 225 |
| Region of Enrollment(participants) | Peginterferon and Ribavirin | Peginterferon | Total |
|---|---|---|---|
| Taiwan | 189 | 188 | 377 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital