NCT01263860

Brief Summary

Patients with HCV genotype 6 infection who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2010

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

3.5 years

First QC Date

December 20, 2010

Last Update Submit

November 14, 2014

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Sustained virological response (SVR)

    Undetectable HCVRNA in serum(\<15IU/ml) 24 weeks after the end of treatment

    24 weeks after the end of treatment

Secondary Outcomes (2)

  • Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment

    24 weeks after the end of treatment

  • Sick leave in patients treated for 24 or 48 weeks treatment

    48 weeks

Study Arms (2)

24-Week treatment group

EXPERIMENTAL

Genotype 6 chronic hepatitis C patients with rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks

Drug: Peginterferon alfa2aDrug: Ribavirin

48-Week treatment group

ACTIVE COMPARATOR

Genotype 6 chronic hepatitis C patients with rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks

Drug: Peginterferon alfa2aDrug: Ribavirin

Interventions

Peginterferon alfa2aDRUG

patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks

24-Week treatment group
RibavirinDRUG

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks

24-Week treatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV RNA is positive
  • Genotype 6
  • Treatment naive
  • Raised ALT

You may not qualify if:

  • Active substance abuse
  • Poorly controlled psychiatric disease
  • HBsAg positive
  • Anti-HIV positive
  • Suffering from other significant concurrent medical conditions including chronic liver diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Eighth People's Hospital of Guangzhou

Guangzhou, Guangdong, 510060, China

Location

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Panyu People's Hospital

Guangzhou, Guangdong, China

Location

Zhongshan second people's hospital

Zhongshan, Guangdong, China

Location

Related Publications (1)

  • Cai Q, Zhang X, Lin C, Shao X, Guan Y, Deng H, Wei M, Huang M, Ren Z, Lu L, Mei Y, Xu M, Zhu J, Shi H, Lin G, Liu Y, Hu F, Luo Q, Lan Y, Guo F, Zhao Z, Gao Z. 24 versus 48 Weeks of Peginterferon Plus Ribavirin in Hepatitis C Virus Genotype 6 Chronically Infected Patients with a Rapid Virological Response: A Non-Inferiority Randomized Controlled Trial. PLoS One. 2015 Oct 28;10(10):e0140853. doi: 10.1371/journal.pone.0140853. eCollection 2015.

    PMID: 26509605DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Gao Zhiliang, Doctor

    The Third Affliated Hospital of Sun Yat-sen University

    STUDY CHAIR

  • Zhao Zhixin, Doctor

    The Third Affliated Hospital of Sun Yat-sen University

    STUDY DIRECTOR

  • Zhang Xiaohong, Doctor

    The Third Affliated Hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Xu Min, Doctor

    The Eighth People's Hospital of Guangzhou

    PRINCIPAL INVESTIGATOR

  • Wei min, Doctor

    Zhongshan second people's hospital

    PRINCIPAL INVESTIGATOR

  • Huang mingshou, Bachelor

    Panyu People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sun Yat-Sen University

Study Record Dates

First Submitted

December 20, 2010

First Posted

December 21, 2010

Study Start

December 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

CN(4)