Double Filtration Plasmapheresis for Hepatitis C Virus (HCV) Genotype 1 Patients With High Viral Load
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Purpose
Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma (HCC) and liver transplantation, affects approximately 170 million individuals worldwide. The prevention of HCV transmission and early intervention of HCV infection are urgently needed to reduce or halt the liver-related morbidity and mortality. Double filtration plasmapheresis (DFPP) has been with widespread use in clinical practice for several indications with plasma filters optimized for the respective elimination targets with excellent safety. By way of the plasma separator, the blood is separated into plasma and cell components. Separated plasma is then led into the plasma component separator where the pores of the plasma component separator further fractionate the plasma into large and small molecular components. The large molecular components, including pathogenic substances, is removed and discarded and the small molecular components, including proteins such as albumin and gamma-globulin, are returned to the patient and mixed with the cell components. After the initiation of pegylated interferon plus ribavirin (Peg-IFN+RBV) therapy, the rapid first phase relates to a significant reduction in virus production and the degradation of free virus particles, which is followed by a second much slower one reflecting the elimination and clearance of infected cells. In HCV patients, high baseline viral load at the initiation of therapy is considered to be a negative predictor for systemic vascular resistance (SVR) for HCV genotype 1 patients. Reduction of baseline viral load by means of therapeutic double filtration plasmapheresis (DFPP) may represent a plausible adjunct for improved antiviral therapy to reduce the virus load with the initiation of treatment in synergy with Peg-IFN and RBV combination therapy. Recently, several clinical studies in evaluating the therapeutic efficacy and safety of DFPP in conjunction with IFN-based therapy were conducted for treatment-naïve genotype 1 high viral load CHC patients, and CHC patients who underwent liver transplantation. These studies showed that patients with DFPP treatment had more favorable HCV early viral kinetics to those without DFPP treatment. Furthermore, all these studies showed excellent safety after DFPP treatment. Therefore, the investigators aimed to conduct a large-scaled randomized controlled trial to evaluate the overall response of DFPP for HCV genotype 1 patients with high viral load.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: DFPP + Peg-IFN + RBV Drug: Peg-IFN + RBV |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Double Filtration Plasmapheresis (DFPP) in Combination With Pegylated Interferon Alfa-2a and Ribavirin for Patients With Chronic Hepatitis C With Genotype 1 and High Viral Load: a Randomized Controlled Trial |
- Sustained virologic response (SVR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Rapid virologic response (RVR) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Treatment-related withdrawal rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 59 |
| Study Start Date: | September 2009 |
| Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DFPP and Peg-IFN + RBV
Double filtration plasmapheresis (Day 1, Day 2, Day 4, Day 8, and Day 9 from the onset of treatment; overall 5 session, each session for 4 hours) and weekly subcutaneous peginterferon alfa-2a 180 ug (week 1 to week 48) and daily oral ribavirin 1,000-1,200 mg (week 1 to week 48; body weight < 75 kg, 1,000 mg/day and body weight >= 75 kg, 1,200 mg/day)
|
Drug: DFPP + Peg-IFN + RBV
Double filtration plasmapheresis: day 1,2,4,8,9 from the onset of treatment (4 hours for each session) Peginterferon alfa-2a: week 1-48, weekly subcutaneous 180 ug Ribavirin: week 1-48, daily oral 1,000-1,200 mg (body weight < 75 kg, 1,000 mg/day; body weight loss >= 75 kg, 1,200 mg/day)
Other Names:
|
|
Active Comparator: Peg-IFN + RBV
Weekly subcutaneous peginterferon alfa-2a 180 ug (week 1 to week 48) and daily oral ribavirin 1,000-1,200 mg (week 1-48; body weight < 75 kg, 1,000 mg/day and body weight >=75 kg, 1,200 mg/day)
|
Drug: Peg-IFN + RBV
Peginterferon alfa-2a: week 1-48, weekly subcutaneous 180 ug Ribavirin: week 1-48, daily oral 1,000-1,200 mg (body weight < 75 kg, 1,000 mg/day; body weight loss >= 75 kg, 1,200 mg/day)
Other Names:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Treatment naïve
- Age 18 and older
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months
- Detectable serum quantitative HCV-RNA (Cobas Taqman v2.0, Roche Diagnostics) with HCV RNA > 800,000 IU/mL
- HCV genotype 1 (Inno-LiPA, Innogenetics)
- A liver biopsy consistent with the diagnosis of chronic hepatitis C
Exclusion Criteria:
- Anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
- Neutropenia (neutrophil count <1,500 per cubic milliliter)
- Thrombocytopenia (platelet <90,000 per cubic milliliter)
- Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Chronic alcohol abuse (daily consumption > 20 gram per day)
- Decompensated liver disease (Child-Pugh class B or C)
- Serum creatinine level more than 1.5 times the upper limit of normal
- Autoimmune liver disease
- Neoplastic disease
- An organ transplant
- Immunosuppressive therapy
- Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
- Evidence of drug abuse
- Unwilling to have contraception
Contacts and Locations| Taiwan | |
| Chiayi Christian Hospital | |
| Chiayi, Taiwan | |
| Buddhist Tzu Chi General Hospital | |
| Chiayi, Taiwan | |
| National Taiwan University Hospital, Yun-Lin Branch | |
| Douliou, Taiwan | |
| Taipei Municipal Hospital | |
| Taipei, Taiwan | |
| Far Eastern Memorial Hospital | |
| Taipei, Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan | |
| Study Chair: | Chen-Hua Liu, MD | National Taiwan University Hospital |
| Study Director: | Jia-Horng Kao, MD, PhD | National Taiwan University Hospital |
| Principal Investigator: | Shih-Jer Hsu, MD | National Taiwan University Hospital, Yun-Lin Branch |
| Principal Investigator: | Cheng-Chao Liang, MD, BS | Far Eastern Memorial Hospital |
| Principal Investigator: | Hung-Bin Tsai, MD | Buddhist Tzu Chi General Hospital |
| Principal Investigator: | Peir-Haur Hung, MD | Chiayi Christian Hospital |
| Principal Investigator: | Chih-Lin Lin, MD, BS | Taipei Municipal Hospital, Ren-Ai Branch |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00977054 History of Changes |
| Other Study ID Numbers: | 200904053D |
| Study First Received: | September 13, 2009 |
| Last Updated: | December 19, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Hepatitis C Peginterferon alfa-2a Ribavirin Plasmapheresis Genotype 1 |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon Alfa-2a Interferon-alpha Ribavirin |
Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Immunologic Factors Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013