Safety Study of Recombinant Interferon Variant(PEG-IFN-SA) to Treat HCV Disease

NCT01605513 | Completed Phase 1 DMC

• 1 other identifier: 2011L0901
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether PEG-IFN-SA is safe, tolerant and effective in the treatment of HCV patients.

Conditions

Hepatitis C Virus

Keywords

recombinant interferon, tolerated, effective

Outcome Measures

Primary Outcomes (1)

• The proportions of absence of detectable HCV RNA after the 12th treatment

  12th week

Secondary Outcomes (5)

• The proportions of absence of detectable HCV RNA after the 4th and 8th treatment

  4th and 8th week

• HCV RNA levels after the 4th, 8th and 12th treatment

  the 4th, 8th and 12th week

• The test of Liver function

  the 2th, 4th, 6th, 8th,10th and 12th week

• The test of Kidney function

  the 2th, 4th, 6th, 8th,10th and 12th week

• The test of Peripheral blood

  the 2th, 4th, 6th, 8th,10th and 12th week

Study Arms (1)

recombinant interferon

EXPERIMENTAL

PEG-IFN-SA 1.0μg/kg for 12 times, Peginterferon alfa-2a 180 μg for 12 times, PEG-IFN-SA 1.5 μg/kg for 12 times, PEG-IFN-SA 2 μg/kg for 12 times, PEG-IFN-SA 3 μg/kg for 12 times, PEG-IFN-SA 1.5μg/kg + ribavirin 0.45g/bid group for 12 times, Intergen 15μg/48hours for 7 times, ribavirin 0.45g/bid for 10 times

Drug: interferon

Interventions

interferon DRUG

PEG-IFN-SA (new interferon) was injected subcutaneously one times per week for 12 times.

recombinant interferon

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• enrolled voluntarily, can understand and sign informed consent;
• More than 18 years and less than 65 years;
• body mass index (BMI) is at 18 - 26;
• anti-HCV antibodies and / or HCV RNA positive, and / or other evidence of chronic hepatitis C;
• HCV RNA level ≥ 2000IU/ml (or equal to this viral load);
• Women's urine pregnancy test was negative, and the subjects (male subjects) is willing to have no pregnancy plans at next 18 months. (7) ALT is within 6 times of the upper limit of normal

You may not qualify if:

• pregnant women, lactating women or plan to pregnant the next 18 months.
• mental disorder, including history of mental illness (especially the history of depression or depressive tendencies, epilepsy, etc.);
• The patient who received interferon therapy within the past six months or had no response at previous interferon therapy.
• The patient who used a strong immune regulator over two weeks with three months before screening, such as adrenocorticotropic hormone, thymosin of α1, thymus 5 peptide.
• The patient who used hepatotoxic drugs with 6 months before screening, such as dapsone, erythromycin, fluconazole, ketoconazole, rifampin.
• co-infection with other viruses (HAV, HBV, HEV, the HIV, EBV, CMV) .
• patients with a history of hepatocellular carcinoma (HCC), or may had hepatocellular carcinoma evidence, such as imaging of suspicious nodules, or AFP abnormal (AFP\> 200ng/mL). FibroScan value greater than or equal to F3 at Screening
• other causes of liver disease: a chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease, nonalcoholic steatohepatitis.
• autoimmune diseases, including psoriasis, systemic lupus erythematosus, thrombocytopenic purpura, and so on.
• heart and vascular system diseases, a history of myocarditis, hypertension, coronary heart disease, pathological arrhythmia, stroke.
• endocrine system diseases, including thyroid disease, diabetes, etc.
• pulmonary diseases, including invasive pulmonary disease, pneumonia, shortness of breath.
• Eye diseases, including retinopathy, retinopathy.
• chronic infectious disease history (history of tuberculosis).
• chronic kidney disease, serum creatinine level\> 1.5 times upper limit of normal at screening, renal insufficiency, renal anemia history.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

Phase One Clinical Trial ward, First Hospital, Jilin University

Changchun, Jilin, 13021, China

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Interferons

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• yanhua ding, associate professor

  First Hospital, Jilin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 25, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

CN (1)