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Chronic Hepatitis CPhase 2NCT01908335

A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C

A Phase 2 study testing PEG-IFN-SA /RBV low dose, PEG-IFN-SA /RBV middle dose and PEG-IFN-SA /RBV high dose in people with Chronic Hepatitis C, run by Beijing Kawin Technology Share-Holding Co., Ltd. at 52 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 dose-escalating study is to evaluate the efficacy and the safety of different doses 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(IFN) by… 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 low dose, PEG-IFN-SA /RBV middle dose and PEG-IFN-SA /RBV high dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
52 sitesChina
Study dates
Oct 2012to Jul 2014
Phase
Phase 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 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
  • 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
  • Hepatotoxic drugs was used for a long time within past 6 months
  • Diagnosed with primary hepatocellular carcinoma or supported by evidences including but not limited to AFP> l00ng/ml, suspicious liver nodules by imaging examinations
  • 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.
Show all 20Show fewer
  • 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 not within the normal range
  • Serum creatine kinase> 3 ULN
  • Positive thyroid antibodies (A-TPO, A-TG)
  • Therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1 etc. within past 6 months or an anticipated usage during the period of study
  • Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
  • Severe autoimmune diseases; psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.); Serious blood disorders (all kinds of anemia, hemophilia, etc.); Severe kidney disease (chronic kidney disease, renal insufficiency, etc.); poorly controlled digestive diseases; endocrine disorders such as thyroid disease and diabetes; severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.); cardiovascular diseases (hypertension, uncontrolled coronary atherosclerotic heart disease, heart failure, etc.); retinal disease; malignancies; or unsuitable for study considered by clinician
  • Function organs transplant
  • 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

52 sites in 1 country.

52 sites in 1 country

China52 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 Union Medical College Hospital

    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

  • Daping Hospital, Research Institute of Surgery Third Military Medical University

    Chongqing

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • Guangdong General Hospital

    Guangzhou, Guangdong

  • Guangzhou Eighth People's Hospital

    Guangzhou, Guangdong

  • Nanfang Hospital Southern Medical Unbiversity

    Guangzhou, Guangdong

  • Xixi Hospital of Hangzhou

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Jinan Infectious Disease Hospital

    Jinan, Shandong

  • Qilu Hospital of Shandong university

    Jinan, Shandong

  • Shandong Provincial Hospital

    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

  • Ruijing Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

  • Shanghai Public Health Clinical Center

    Shanghai

  • The Sixth People's Hospital of Shenyang

    Shenyang, Liaoning

  • The third people's hospital of Shenzhen

    Shenzhen, Guangdong

  • Third Affiliated Hospital, Hebei Medical University

    Shijiazhuang, Hebei

  • The first affiliated hospital of suzhou university

    Suzhou, Jiangsu

  • 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

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Phase Ⅱ, 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 dose-escalating study is to evaluate the efficacy and the safety of different doses 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(IFN) by exploring the dose-effect relationship, while identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method is adopted to assess the pharmacokinetic behavior, individuals / intra-individual variability, and the possible factors for further study.

Read the detailed description

Total 200 subjects will be randomized and enrolled into four groups proportionally receiving experimental drug of high dose, middle dose, low dose and positive-control drug. Treatment duration will be 24 or 48 weeks corresponding to different HCV genotype, genotype 2,3 and non-genotype2,3.

Being tested
PEG-IFN-SA /RBV low dose, PEG-IFN-SA /RBV middle dose, PEG-IFN-SA /RBV high dose, Pegasys /RBV
Keywords
interferon, ribavirin, 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 /RBV low doseDrug

    24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3

  • PEG-IFN-SA /RBV middle doseDrug

    24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3

  • PEG-IFN-SA /RBV high doseDrug

    24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3

  • Pegasys /RBVDrug

    24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3

Study groups in NCT01908335
Study groupRoleWhat they receive
A (PEG-IFN-SA /RBV low dose)ExperimentalPEG-IFN-SA 0.75μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）
Receives: Drug: PEG-IFN-SA /RBV low dose
B (PEG-IFN-SA /RBV middle dose)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）
Receives: Drug: PEG-IFN-SA /RBV middle dose
C (PEG-IFN-SA /RBV high dose)ExperimentalPEG-IFN-SA 2.0μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）
Receives: Drug: PEG-IFN-SA /RBV high dose
D (Pegasys /RBV)Active comparatorPegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）
Receives: Drug: Pegasys /RBV

What is being measured

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

  1. cEVR (complete early virologic response)

    defined as the proportion of patients who had undetectable plasma HCV RNA at weeks 12

    Measured: weeks 12 of study therapy

Secondary outcomes (5)

  1. Proportion of patients who had undetectable plasma HCV RNA

    Measured: weeks 4, 24, 48 of study therapy and 24 weeks after the end of treatment

  2. HCV RNA load reduction

    Measured: weeks 4, 12, 24, 48 of study therapy and 24 weeks after the end of treatment

  3. eRVR ( extended rapid virologic response)

    defined as the proportion of patients who had undetectable plasma HCV RNA at weeks 4 and 12

    Measured: weeks 4 and 12 of study therapy

  4. 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 24, 48 of study therapy

  5. Relapse

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

    Measured: 12 and 24 weeks after the end of treatment

Timeline

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

  1. First posted25 Jul 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionAug 2013
  4. Study completionJul 2014

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01908335
Sponsor's protocol ID
KAWIN-002-1
Status last verified
Oct 2014
First submitted
23 Jul 2013
Last updated
20 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEG-IFN-SA /RBV low dose, PEG-IFN-SA /RBV middle dose and PEG-IFN-SA /RBV high dose in people with Chronic Hepatitis C, run by Beijing Kawin Technology Share-Holding Co., Ltd. at 52 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 20 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 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 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 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?

cEVR (complete early virologic response) (time frame: weeks 12 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 NCT01908335.

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 20 Oct 2014.

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