Patterns of Early Hepatitis C Virus Decline Predict the Outcome of Interferon Therapy (sIFN-pred2)

NCT01760148 | Unknown DMC

• 3 other identifiers: 2012ZX100020072009ZX10004-105-jida022008ZX10002-014-jida02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to validate the first round HCV early dynamics discovery within a larger population.

Conditions

Hepatitis C, Chronic; Liver Diseases; Interferon Deficiency

Keywords

Hepatitis C Virus; HCV; Interferon; Prediction; SVR; Sustained Virus Response

Outcome Measures

Primary Outcomes (1)

• Absolute Blood HCV RNA Copies at designed time points

  Blood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.

  0hr,24hr,1wk,2wk,4wk,6wk,12wk,24wk,48wk,72wk

Secondary Outcomes (8)

• IL-28B polymorphism

  Baseline

• HCV genotype

  Baseline

• Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)

  Baseline,4wk,12wk,24wk,48wk

• Fibrosis stage

  Baseline,4wk,12wk,24wk,48wk

• Regular blood test

  Baseline,4wk,12wk,24wk,48wk

Study Arms (1)

Interferon and ribavirin

All the patients followed the standard treatment protocol.

Drug: interferon alpha 2b

Interventions

interferon alpha 2b DRUG

Interferon:dosage,5 million units/person;frequency,every other day (qod);duration,48 weeks;Subcutaneous injection. Ribavirin: dosage,15mg/kg/day;frequency,three times a day (t.i.d);duration,48 weeks;take orally.

Also known as: Other Names:IFN+Ribavirin, Generic: Recombinant Human Interferon alpha-2b,Ribavirin, Brand: Kaiyinyisheng,Weilake, FDA Approval number:S20030032,H10940157

Interferon and ribavirin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are from the northeast of China. Most of the patients have been infected by the hepatitis c virus due to the drug abuse. Many of them share the same syringe for drug intravenous injection. However, HIV infection has been rarely detected.

You may qualify if:

• Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
• Serum HCV-RNA \> 3 log IU/ml
• Has been infected by HCV for more than 6 months
• ALT,AST have been elevated continuously, inflammation and necrosis have been observed according to the histology diagnosis (G\>=2),modest liver fibrosis (S\>=2)For those patients whose ALT are normal,treatment accord to the liver biopsy. If obvious fibrosis has been detected (S2,S3),treatment should be done.For those S0,S1 stage patients, treatment could be delayed, but ALT/AST should be assayed every 3-6 months.
• Compensated liver disease
• Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin

You may not qualify if:

• History:
• Has history of decompensated liver diseases
• Has been treated with other anti-virus drugs,or anti-tumor drugs,immuno-suppression drugs
• Has a history of autoimmune hepatitis
• History of a severe seizure disorder or current anticonvulsant use
• History or other evidence of a medical condition associated with chronic liver disease other than HCV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
• History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
• Current condition:
• Pregnant women or women during the lactation period
• Co-infected with hepatitis b virus or human immunodeficiency virus
• Liver cancer or alpha-fetoprotein \> 100ng/ml
• Blood neutrophils count \< 1500/mm3, or platelets count \< 90000/mm3
• Female hemoglobin \<11.5g/dL, male hemoglobin \<12.5g/dL
• Blood creatinine \> 1.5 ULN

Sponsors & Collaborators

• Junqi Niu: lead
• Chinese Academy of Sciences: collaborator

Study Sites (1)

First Hospital Jilin University

Changchun, Jilin, 130061, China

RECRUITING

Related Publications (7)

• Neumann AU, Lam NP, Dahari H, Gretch DR, Wiley TE, Layden TJ, Perelson AS. Hepatitis C viral dynamics in vivo and the antiviral efficacy of interferon-alpha therapy. Science. 1998 Oct 2;282(5386):103-7. doi: 10.1126/science.282.5386.103.

  PMID: 9756471 BACKGROUND

• Dahari H, Ribeiro RM, Perelson AS. Triphasic decline of hepatitis C virus RNA during antiviral therapy. Hepatology. 2007 Jul;46(1):16-21. doi: 10.1002/hep.21657.

  PMID: 17596864 BACKGROUND

• Snoeck E, Chanu P, Lavielle M, Jacqmin P, Jonsson EN, Jorga K, Goggin T, Grippo J, Jumbe NL, Frey N. A comprehensive hepatitis C viral kinetic model explaining cure. Clin Pharmacol Ther. 2010 Jun;87(6):706-13. doi: 10.1038/clpt.2010.35. Epub 2010 May 12.

  PMID: 20463660 BACKGROUND

• Dixit NM, Layden-Almer JE, Layden TJ, Perelson AS. Modelling how ribavirin improves interferon response rates in hepatitis C virus infection. Nature. 2004 Dec 16;432(7019):922-4. doi: 10.1038/nature03153.

  PMID: 15602565 BACKGROUND

• Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65. doi: 10.1016/s0140-6736(01)06102-5.

  PMID: 11583749 BACKGROUND

• Dill MT, Duong FH, Vogt JE, Bibert S, Bochud PY, Terracciano L, Papassotiropoulos A, Roth V, Heim MH. Interferon-induced gene expression is a stronger predictor of treatment response than IL28B genotype in patients with hepatitis C. Gastroenterology. 2011 Mar;140(3):1021-31. doi: 10.1053/j.gastro.2010.11.039. Epub 2010 Nov 25.

  PMID: 21111740 BACKGROUND

• Araujo ES, Dahari H, Neumann AU, de Paula Cavalheiro N, Melo CE, de Melo ES, Layden TJ, Cotler SJ, Barone AA. Very early prediction of response to HCV treatment with PEG-IFN-alfa-2a and ribavirin in HIV/HCV-coinfected patients. J Viral Hepat. 2011 Apr;18(4):e52-60. doi: 10.1111/j.1365-2893.2010.01358.x.

  PMID: 20738775 BACKGROUND

Related Links

• Hospital's homepage
• Coperator's Homepage
• Homepage of Jilin University

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum,Peripheral blood mononuclear cells (PBMC)

MeSH Terms

Conditions

Hepatitis C, Chronic; Liver Diseases; Hepatitis C

Interventions

Interferon alpha-2

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Bing Sun, Doctor

  Chinese Academy of Sciences

  STUDY CHAIR

• Chen Yang, Doctor

  Chinese Academy of Sciences

  STUDY DIRECTOR

Central Study Contacts

Chen Yang, PhD

CONTACT

+8615221296266; yangch@zoho.com

Xiumei Chi, PhD

CONTACT

+862154921375; xiumeichi@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 8, 2012
• First Posted: January 4, 2013
• Study Start: July 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 4, 2013

Record last verified: 2013-01

Locations

CN (1)