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Hepatitis C VirusPhase 1/2PEG-IFN-SANCT01605513

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

A Phase 1/2 study testing interferon in people with Hepatitis C Virus, run by The First Hospital of Jilin University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Hepatitis C Virus
What is being tested?
interferon
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
Jun 2011to Dec 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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) .
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  • 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.
  • anemia (including thalassemia, sickle hemoglobin, anemia), and hemophilia.
  • peptic ulcer not controlled, colitis, pancreatitis and others.
  • malignancies.
  • 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.
  • serum total bilirubin> 2 times normal maximum reference value (ULN); serum albumin <35g / L; a history of decompensated cirrhosis evidence.
  • 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.
  • a serious history of drug and food allergy, especially towards the test drug (interferon, ribavirin).
  • plans to accept an organ transplant or have organ transplant.
  • participated other clinical trials before 3 months at screening
  • The researchers judged the patients have other factors which may influence the experiment.
  • ribavirin exclusion criteria:
  • women Hgb <12g/dl or men Hgb <13gdl at screening.
  • anemia patients (eg, thalassemia, spherocytosis hyperlipidemia, gastrointestinal bleeding history) or suspected anemia patients.
  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Phase One Clinical Trial ward, First Hospital, Jilin University

    Changchun, Jilin, 13021

Other trials in China

About this study

Official title: Phase I Clinical Trial of PEG-IFN-SA in HCV Disease: Evidence for Drug Safety, Tolerance, and Antiviral Activity

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

Read the 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.

Being tested
interferon
Keywords
recombinant interferon, tolerated, effective
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • interferonDrug

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

Study groups in NCT01605513
Study groupRoleWhat they receive
recombinant interferonExperimentalPEG-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
Receives: Drug: interferon

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12th week

Secondary outcomes (5)

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

    Measured: 4th and 8th week

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

    Measured: the 4th, 8th and 12th week

  3. The test of Liver function

    Liver function test:TBIL,IBIL, ALT, AST;

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

  4. The test of Kidney function

    Kidney function test:BUN, CR;

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

  5. The test of Peripheral blood

    Peripheral blood detection:WBC, RBC, HgB,PLT, neutrophil

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2012 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01605513
Sponsor's protocol ID
2011L0901
Acronym
PEG-IFN-SA
Status last verified
Jan 2016
First submitted
10 May 2012
Last updated
26 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing interferon in people with Hepatitis C Virus, run by The First Hospital of Jilin University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportions of absence of detectable HCV RNA after the 12th treatment (time frame: 12th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01605513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.

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