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Chronic Hepatitis CPhase 2PEGIFNNCT01140997

Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C

A Phase 2 study testing Ypeginterferon alfa-2b and Peginterferon alfa-2a in people with Chronic Hepatitis C, run by Xiamen Amoytop Biotech Co., Ltd. at 38 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 a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week \& Ribavirin as positive… 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?
Ypeginterferon alfa-2b and Peginterferon alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
38 sitesChina
Study dates
Jul 2010to Mar 2012
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.
  • Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
  • Chronic HCV infection evidence: HCV RNA or anti-HCV positive >6 months; liver biopsy evidence; vital signs, symptoms, exposure history, and results of laboratory test and iconography examination support diagnosis of chronic hepatitis C.
  • HCV RNA≥2000IU/ml.

Who cannot join

  • Pregnant or lactating women.
  • Mental disorder or physical disability.
  • WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
  • Received interferon treatment within the previous 6 months or shew no response to interferon.
  • Co-infection with HIV, HAV, HBV, HEV.
  • Evidence of hepatic decompensation.
Show all 10Show fewer
  • Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
  • History of hypothyroidism or current treatment for thyroid disease.
  • Diabetes mellitus.
  • Uncontrolled significant chronic medical conditions other than chronic hepatitis C or other conditions which in the opinion of the investigator preclude enrollment into the study.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

China38 sites

  • 302 Military Hospital

    Beijing

  • Beijing Youan Hospital, Capital Medical University

    Beijing

  • Beijing Youyi Hospital, Capital Medical University

    Beijing

  • Peking University First Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • First Affiliated Hospital of Jilin University

    Changchun

  • Xiangya Hospital, Central-south University

    Changsha

  • Xiangya Second Hospital, Central-south University

    Changsha

  • West China Hospital, Sichuan University

    Chengdu

  • Second Affiliated Hospital Chongqing Medical University

    Chongqing

  • Southwest Hospital

    Chongqing

  • Fuzhou Infectious Disease Hospital

    Fuzhou

  • Guangzhou Eighth People's Hospital

    Guangzhou

  • Nangfang Hospital

    Guangzhou

  • First Affiliated Hospital of Guangxi Medical Universtiy

    Guilin

  • Second Affiliated Hospital of Harbin Medical University

    Harbin

  • First Affiliated Hospital of Anhui Medical University

    Hefei

  • Jinan Infectious Disease Hospital

    Jinan

  • First Affiliated Hospital of Lanzhou University

    Lanzhou

  • First Affiliated Hospital of Nanchang University

    Nanchang

  • 81 Military Hospital

    Nanjing

  • Jiangsu Province Hospital

    Nanjing

  • Second Hospital of Nanjing

    Nanjing

  • 85 Military Hospital

    Shanghai

  • Changhai Hospital

    Shanghai

  • Huashan Hospital

    Shanghai

  • Renji Hospital

    Shanghai

  • Ruijin Hospital

    Shanghai

  • Shanghai Public Health Clinical Center

    Shanghai

  • Shenzhen Third People's Hospital

    Shenzhen

  • Third Affiliated Hospital, Hebei Medical University

    Shijiazhuang

  • First Affiliated Hospital, Shanxi University

    Taiyuan

  • Tianjin Third Central Hospital

    Tianjin

  • First Affiliated Hospital of Wenzhou Medical College

    Wenzhou

  • Tongji Hospital, Huazhong University of Science&Technology

    Wuhan

  • Tangdu Hospital, Fouth Military Medical University

    Xi'an

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • Henan Provincial People's Hospital

    Zhengzhou

Other trials in China

About this study

Official title: A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C.

This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week \& Ribavirin as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory requirements.

Being tested
Ypeginterferon alfa-2b, Peginterferon alfa-2a
Keywords
HCV, CHC, Hepatitis C, Chronic, Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepadnaviridae Infections, Antiviral Agents, Virus Diseases, Peginterferon alfa
Medical subject headings
Hepatitis C, Chronic, Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepadnaviridae Infections, Virus Diseases

What participants receive

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

  • Ypeginterferon alfa-2bDrug

    Also called Peginterferon alfa-2b

    sc, qw, for 48 weeks.

  • Peginterferon alfa-2aDrug

    Also called Pegasys

    sc, qw, for 48 weeks.

Study groups in NCT01140997
Study groupRoleWhat they receive
Group 1ExperimentalYpeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
Receives: Drug: Ypeginterferon alfa-2b
Group 2ExperimentalYpeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
Receives: Drug: Ypeginterferon alfa-2b
Group 3ExperimentalYpeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
Receives: Drug: Ypeginterferon alfa-2b
Group 4Active comparatorPegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
Receives: Drug: Peginterferon alfa-2a

What is being measured

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

  1. Efficacy

    Proportion of patients with HCV RNA undetectable at week 12.

    Measured: week 12

Secondary outcomes (1)

  1. Efficacy

    1. Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72;
    2. Average decline level of log10 of HCV RNA at Week 4, 12, 24, 48 and 72.

    Measured: Week 4, 12, 24, 48 and 72

Timeline

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

  1. First posted10 Jun 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionJan 2011
  4. Study completionMar 2012

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
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01140997
Sponsor's protocol ID
TB1006IFN
Acronym
PEGIFN
Status last verified
Jun 2010
First submitted
8 Jun 2010
Last updated
4 Feb 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Feng B, Yang RF, Xie Q, Shang J, Kong FY, Zhang HY, Rao HY, Jin Q, Cong X, Liu YY, Kang Y, Wei L. Hepatitis C virus core antigen, an earlier and stronger predictor on sustained virological response in patients with genotype 1 HCV infection. BMC Gastroenterol. 2014 Mar 13;14:47. doi: 10.1186/1471-230X-14-47.

    PubMed 24625322

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ypeginterferon alfa-2b and Peginterferon alfa-2a in people with Chronic Hepatitis C, run by Xiamen Amoytop Biotech Co., Ltd. at 38 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 4 inclusion and 10 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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?

Efficacy (time frame: week 12). 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 NCT01140997, which also lists 1 linked publication.

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 4 Feb 2013.

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