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Double Filtration Plasmapheresis for Hepatitis C Virus (HCV) Genotype 1 Patients With High Viral Load

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ClinicalTrials.gov Identifier: NCT00977054
Recruitment Status : Terminated (Novel HCV DAA approved by FDA)
First Posted : September 15, 2009
Last Update Posted : December 20, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Drug: DFPP + Peg-IFN + RBV Drug: Peg-IFN + RBV Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2009
Estimated Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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:
  • DFPP: Plasmaflo + Cascadeflo EC-50W (Asahi)
  • Peg-IFN alfa-2a: Pegasys (Hoffman La-Roche)
  • RBV: Copegus (Hoffman La-Roche)
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:
  • Peg-IFN alfa-2a: Pegasys (Hoffman La-Roche)
  • RBV: Copegus (Hoffman La-Roche)

Outcome Measures

Primary Outcome Measures :
  1. Sustained virologic response (SVR) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Rapid virologic response (RVR) [ Time Frame: 1 month ]
  2. Treatment-related withdrawal rate [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977054

Buddhist Tzu Chi General Hospital
Chiayi, Taiwan
Chiayi Christian Hospital
Chiayi, Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Douliou, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Municipal Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Department of Health, Executive Yuan, R.O.C. (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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00977054     History of Changes
Other Study ID Numbers: 200904053D
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by National Taiwan University Hospital:
Hepatitis C
Peginterferon alfa-2a
Genotype 1

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs