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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by First Hospital of Jilin University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Yanhua Ding, First Hospital of Jilin University
ClinicalTrials.gov Identifier:
NCT01605513
First received: May 10, 2012
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Hepatitis C Virus
Drug: interferon
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of PEG-IFN-SA in HCV Disease: Evidence for Drug Safety, Tolerance, and Antiviral Activity

Resource links provided by NLM:


Further study details as provided by First Hospital of Jilin University:

Primary Outcome Measures:
  • The proportions of absence of detectable HCV RNA after the 12th treatment [ Time Frame: 12th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportions of absence of detectable HCV RNA after the 4th and 8th treatment [ Time Frame: 4th and 8th week ] [ Designated as safety issue: No ]
  • HCV RNA levels after the 4th, 8th and 12th treatment [ Time Frame: the 4th, 8th and 12th week ] [ Designated as safety issue: No ]
  • The test of Liver function [ Time Frame: the 2th, 4th, 6th, 8th,10th and 12th week ] [ Designated as safety issue: Yes ]
    Liver function test:TBIL,IBIL, ALT, AST;

  • The test of Kidney function [ Time Frame: the 2th, 4th, 6th, 8th,10th and 12th week ] [ Designated as safety issue: Yes ]
    Kidney function test:BUN, CR;

  • The test of Peripheral blood [ Time Frame: the 2th, 4th, 6th, 8th,10th and 12th week ] [ Designated as safety issue: Yes ]
    Peripheral blood detection:WBC, RBC, HgB,PLT, neutrophil


Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: recombinant interferon
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
PEG-IFN-SA (new interferon) was injected subcutaneously one times per week for 12 times.

Detailed Description:

Chronic infection with the hepatitis C virus (HCV) is a significant public health problem in china. Progressive liver disease, as a result of chronic HCV infection, usually develops slowly over 20-50 years and may lead to cirrhosis, hepatocellular carcinoma, liver failure and eventual death. Symptoms are typically mild and non-specific but nevertheless can cause a decrease in quality of life. Peginterferon alfa and ribavirin combination therapy is currently used in the china for treatment of chronic HCV. Successful treatment is considered to be attainment of a sustained virological response (SVR), defined as undetectable serum HCV ribonucleic acid (RNA) 6 months after cessation of treatment.

PEG-IFN-SA is a new recombinant interferon variant. Its N-terminus is modified by 20KD molecular weight single-methoxy polyethylene glycol (PEG). It consists of 171 amino acids before modification. PEG-IFN-SA is reorganization, unnatural existence and a new type of interferon (171Arg126Asp171IFN) after modification. The safety, tolerance and antiviral activity of PEG-IFN-SA was tested in adults with HCV infection.

PEG-IFN-SA was injected subcutaneously one times per week for 12 times. Peginterferon alfa-2a (Pegasys) is the positive control drug. 80 patients were randomly assigned to eight groups (PEG-IFN-SA 1.0μg/kg, Peginterferon alfa-2a 180 μg, PEG-IFN-SA 1.5 μg/kg,PEG-IFN-SA 2 μg/kg, PEG-IFN-SA 3 μg/kg,PEG-IFN-SA 1.5μg/kg + ribavirin 0.45g/bid group,Intergen 15μg/48hours for 7 times and ribavirin 0.45g/bid for 10 times).

Clinical and biological adverse effects were recorded every week such as headache, nausea and vomiting. HCV RNA level was tested by COBAS Taqman HCV Test system of Roche. Blood cell counts were tested using an automatic cell counter such as WBC, neutrophil, PLT and HGB. Biochemical indicators were tested by automatic biochemical analysis instrument.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. enrolled voluntarily, can understand and sign informed consent;
  2. More than 18 years and less than 65 years;
  3. body mass index (BMI) is at 18 - 26;
  4. anti-HCV antibodies and / or HCV RNA positive, and / or other evidence of chronic hepatitis C;
  5. HCV RNA level ≥ 2000IU/ml (or equal to this viral load);
  6. 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

Exclusion Criteria:

  1. pregnant women, lactating women or plan to pregnant the next 18 months.
  2. mental disorder, including history of mental illness (especially the history of depression or depressive tendencies, epilepsy, etc.);
  3. The patient who received interferon therapy within the past six months or had no response at previous interferon therapy.
  4. 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.
  5. The patient who used hepatotoxic drugs with 6 months before screening, such as dapsone, erythromycin, fluconazole, ketoconazole, rifampin.
  6. co-infection with other viruses (HAV, HBV, HEV, the HIV, EBV, CMV) .
  7. 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
  8. other causes of liver disease: a chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease, nonalcoholic steatohepatitis.
  9. autoimmune diseases, including psoriasis, systemic lupus erythematosus, thrombocytopenic purpura, and so on.
  10. heart and vascular system diseases, a history of myocarditis, hypertension, coronary heart disease, pathological arrhythmia, stroke.
  11. endocrine system diseases, including thyroid disease, diabetes, etc.
  12. pulmonary diseases, including invasive pulmonary disease, pneumonia, shortness of breath.
  13. Eye diseases, including retinopathy, retinopathy.
  14. chronic infectious disease history (history of tuberculosis).
  15. chronic kidney disease, serum creatinine level> 1.5 times upper limit of normal at screening, renal insufficiency, renal anemia history.
  16. anemia (including thalassemia, sickle hemoglobin, anemia), and hemophilia.
  17. peptic ulcer not controlled, colitis, pancreatitis and others.
  18. malignancies.
  19. peripheral blood checking: white blood cell count <3 × 109 / L; neutrophil count <1.5 x 109 / L; platelet count <90 × 109 / L; hemoglobin was less than the normal reference limit.
  20. serum total bilirubin> 2 times normal maximum reference value (ULN); serum albumin <35g / L; a history of decompensated cirrhosis evidence.
  21. evidence of drug addiction (including excessive alcohol intake, average alcohol consumption: men> 40g / day; women> 20g / day, equivalent to 50 degrees white wine 100ml / day and 50ml / day) within one year before screening.
  22. a serious history of drug and food allergy, especially towards the test drug (interferon, ribavirin).
  23. plans to accept an organ transplant or have organ transplant.
  24. participated other clinical trials before 3 months at screening
  25. The researchers judged the patients have other factors which may influence the experiment.

ribavirin exclusion criteria:

  1. women Hgb <12g/dl or men Hgb <13gdl at screening.
  2. anemia patients (eg, thalassemia, spherocytosis hyperlipidemia, gastrointestinal bleeding history) or suspected anemia patients.
  3. patients have a history of coronary artery disease or patients with cerebrovascular disease should not join this study, hemoglobin decline up to 4g/dl (it may be observed in the ribavirin treatment).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605513

Locations
China, Jilin
Phase One Clinical Trial ward, First Hospital, Jilin University
Changchun, Jilin, China, 13021
Sponsors and Collaborators
First Hospital of Jilin University
Investigators
Study Director: yanhua ding, associate professor First Hospital, Jilin University
  More Information

No publications provided

Responsible Party: Yanhua Ding, associate professor, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT01605513     History of Changes
Other Study ID Numbers: 2011L0901
Study First Received: May 10, 2012
Last Updated: May 23, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by First Hospital of Jilin University:
recombinant interferon, tolerated, effective

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
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 26, 2014