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Chronic Hepatitis cPhase 3NCT01903278

Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C

A Phase 3 study testing PEG-IFN-SA /RBV and Pegasys /RBV in people with Chronic Hepatitis c, run by Beijing Kawin Technology Share-Holding Co., Ltd. at 41 sites 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

This study is to confirm the potential effects and assess the safety of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated with Interferon. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis c
What is being tested?
PEG-IFN-SA /RBV and Pegasys /RBV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
719 participants
Where
41 sitesChina
Study dates
Jun 2013to Aug 2015
Phase
Phase 3
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18- 65 years
  • Body Mass Index (BMI) 18-30
  • Chronic hepatitis C , diagnosed according to Chinese guideline of Hepatitis C (year 2004)
  • Detectable serum HCV-RNA by quantitative polymerase chain reaction assay and positive anti-HCV antibody
  • Female subjects of childbearing age with no history of menopause and negative pregnancy test, both female and male( including their partners ) subjects were required to conduct adequate contraception since screening until the 6 months after treatment
  • Volunteered to participate in this study, understood and signed an informed consent

Who cannot join

  • Previous IFN treated patients
  • Hepatotoxic drugs was systematically used more than two weeks within past 6 months
  • Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids
  • Co-infection with HAV, HBV, HEV, EBV, CMV and HIV
  • Evidences of hepatic decompensation, including but not limited to serum total bilirubin> 2 times the upper limit of normal (ULN); serum albumin <35g/L; prothrombin activity (PTA) <60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade
  • Diagnosed with primary hepatocellular carcinoma or supported by evidences including but not limited to AFP> l00ng/ml, suspicious liver nodules by imaging examinations
Show all 29Show fewer
  • Liver diseases from causes other than HCV infection, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
  • White blood cell count <3×109/L; Neutrophil count<1.5×109/L; platelet count<90×109/L; hemoglobin below the lower limit of normal
  • Serum creatinine above the ULN
  • Serum creatine kinase> 3 ULN
  • Diabetes mellitus or Poorly controlled Thyroid Diseases
  • Poorly controlled hypertension (systolic blood pressure> 140mmHg, or diastolic blood pressure> 90 mmHg) with hypertension -related retinal lesions
  • Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
  • Psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
  • Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias)
  • Serious blood disorders (all kinds of anemia, hemophilia, etc.)
  • Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
  • Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
  • Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
  • Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
  • Malignancies
  • Function organs transplant
  • Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
  • Evidence of alcohol or drug abuse (average alcohol consumption male> 40g / day, female> 20g / day)
  • Pregnant or lactating women
  • Usage of prohibition drugs in this study
  • Participated in other clinical trials 3 months prior to the screening
  • Unwilling to sign the informed consent and adhere to treatment requirements
  • Other conditions not suitable for study judged by investigators

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

China41 sites

  • 302 Military Hospital of China

    Beijing

  • Beijing Ditan Hospital, Capital Medical University

    Beijing

  • Beijing Youan Hospital, Capital Medical University

    Beijing

  • Beijing Youyi Hospital, capital Medical University

    Beijing

  • General Hospital of Beijing Military Region

    Beijing

  • Peking University First Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • The First Affiliated Hospital of Jilin University

    Changchun, Jilin

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital Central-South University

    Changsha, Hunan

  • Sichuan Academy of Medical Science ＆Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • Chongqing Southwest Hospital

    Chongqing

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Guangzhou Eighth People's Hospital

    Guangzhou, Guangdong

  • Nanfang Hospital Southern Medical Unbiversity

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Jinan Infectious Disease Hospital

    Jinan, Shandong

  • Qilu Hospital of Shandong university

    Jinan, Shandong

  • First Affiliated Hospital of Lanzhou University

    Lanzhou, Gansu

  • First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu province hospital

    Nanjing, Jiangsu

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Qingdao Municipal Hospital

    Qingdao, Shandong

  • Shanghai Public Health Clinical Center

    Shanghai

  • The Sixth People's Hospital of Shenyang

    Shenyang, Liaoning

  • Third Affiliated Hospital, Hebei Medical University

    Shijiazhuang, Hebei

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Tianjin Infectious Disease Hospital

    Tianjin

  • The First Teaching Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Tongji Hospital, Tongji Medical College Huazhong University of Science ＆ Technology

    Wuhan, Hubei

  • Union hospital, Tongji Medical College Huazhong University of Science ＆ Technology

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • First Affiliated Hospital Of Medical College of Xian Jiaotong University

    Xi'an, Shaanxi

  • Second Affiliated Hospital Of Medical College of Xian Jiaotong University

    Xi'an, Shaanxi

  • Tangdu Hospital，Fourth Military Medical University

    Xi'an, Shaanxi

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

  • Yanbian University Hospital (Yanbian Hospital)

    Yanji, Jilin

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Multi-center, Randomized, Open-label, Parallel-group, Active Controlled Study for the Efficacy and Safety of Pegylated Recombinant Consensus Interferon Variant Solution for Injection in the Treatment of Chronic Hepatitis C

This study is to confirm the potential effects and assess the safety of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated with Interferon.

Read the detailed description

Total 720 subjects are divided into two groups and treated separately according to the HCV genotype（genotype 2,3 and non-genotype 2,3). With 2:1 ratio between experimental group and positive-control group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype 2,3 and 504 subjects for non-genotype2,3 will be enrolled. Accordingly, PEG-IFN-SA once weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV genotype 2,3 and the HCV non-genotype 2,3 .

Being tested
PEG-IFN-SA /RBV, Pegasys /RBV
Keywords
interferon, ribavirin, sustained virological response
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • PEG-IFN-SA /RBVDrug

  • Pegasys /RBVDrug

Study groups in NCT01903278
Study groupRoleWhat they receive
PEG-IFN-SA /RBV T1(Genotype2,3)ExperimentalPEG-IFN-SA/RBV, 1.5μg/kg/week im and RBV 1000mg-1200mg/d po bid（BW<75kg,1000mg/d; BW≥75kg, 1200mg/d）,24 weeks
Receives: Drug: PEG-IFN-SA /RBV
Pegasys /RBV C1(Genotype 2,3)Active comparatorPegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 24 weeks
Receives: Drug: Pegasys /RBV
PEG-IFN-SA /RBV T2(Non-genotype 2,3)ExperimentalPEG-IFN-SA 1.5μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
Receives: Drug: PEG-IFN-SA /RBV
Pegasys /RBV C2(Non-genotype 2,3)Active comparatorPegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
Receives: Drug: Pegasys /RBV

What is being measured

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

  1. SVR (sustained virologic response)

    defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of SVR (sustained virologic response) defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of treatment

    Measured: 24 weeks after 24 or 48 weeks of study therapy

Secondary outcomes (7)

  1. RVR(rapid virologic response)

    defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4

    Measured: weeks 4 of study therapy

  2. cEVR (complete early virologic response)

    defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 12

    Measured: weeks 12 of study therapy

  3. ETVR( end of treatment virologic response)

    defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at the end of treatment

    Measured: weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3

  4. eRVR ( extended rapid virologic response)

    defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4 and 12

    Measured: weeks 4 and 12 of study therapy

  5. No-responses

    defined as the proportion of patients who had less than a <2 log IU/ml plasma HCV RNA decline at weeks 12 or had detectable plasma HCV RNA at weeks 24

    Measured: weeks 12 or weeks 24 of study therapy

  6. Breakthrough

    defined as the proportion of patients who had detectable plasma HCV RNA at any point during treatment after virological response( undetectable plasma HCV RNA)

    Measured: weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3

  7. Relapse

    defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after the then

    Measured: 12 and 24 weeks after 24 or 48 weeks of study therapy

Timeline

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

  1. First posted19 Jul 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
719 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01903278
Sponsor's protocol ID
KAWIN-002-2
Status last verified
Sep 2015
First submitted
17 Jul 2013
Last updated
25 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PEG-IFN-SA /RBV and Pegasys /RBV in people with Chronic Hepatitis c, run by Beijing Kawin Technology Share-Holding Co., Ltd. at 41 sites 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 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

SVR (sustained virologic response) (time frame: 24 weeks after 24 or 48 weeks of study therapy). 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 NCT01903278.

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 25 Sep 2015.

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