HCV (Hepatitis C Virus) Viral and Host Genotyping (IL28B, Interleukin 28B) in China
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | February 9, 2011 | ||||||||
| Last Updated Date | October 6, 2011 | ||||||||
| Start Date ICMJE | February 2011 | ||||||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Hepatitis C viral and host genotypes [ Time Frame: Confirmation of an HCV infection 30 days prior to the recruitment ] [ Designated as safety issue: No ] To describe the distributions of both HCV viral and host genotypes (IL28B and ITPA) among antiviral treatment naive HCV patients |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01293279 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Hepatitis C RNA levels [ Time Frame: Confirmation of an HCV infection 30 days prior to the recruitment ] [ Designated as safety issue: No ] To describe the distribution of HCV RNA levels in antiviral treatment-naive HCV patients |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | HCV (Hepatitis C Virus) Viral and Host Genotyping (IL28B, Interleukin 28B) in China | ||||||||
| Official Title ICMJE | HCV Viral Genotyping Distribution and Genetic Variation in IL28B Distributions Among the Han Ethnic Chinese in China | ||||||||
| Brief Summary | The primary objective of this study is to estimate the distributions of HCV viral/human genotypes (including IL28B and inosine triphosphatase, ITPA), and HCV RNA level among ITPA gene among 1000 Han ethnic Chinese patients with HCV who are antiviral treatment naive at the time the study is conducted. |
||||||||
| Detailed Description | A sample of 1000 Han ethnic Chinese male or female who are ≥ 18 years old with a recent confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral treatment naive from 28 university affiliated hospital in China. The primary objective of this study is to estimate the distributions of HCV Viral genotyping(ie, genotype 1 through 6 and their known subtypes), and host genotypes, both inosine triphosphatase (ITPA) gene, and IL28B. This study also collects other data including patients' demographic and clinical characteristics. There is no active antiviral treatments and no follow-up in this study. |
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: By having the approvals from the EC and China National Human Genetic Resource Management Office (under China Ministry of Health) and having the patient informed consent, blood samples of all recruited patients will be retained under the proper conditions in Peking University People's Hospital, Beijing, China |
||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | 1000 Han ethnic Chinese in China |
||||||||
| Condition ICMJE | Hepatitis C | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | HCV Patients who are treatment naive
Han ethnic Chinese male or female ≥ 18 years old with recent a confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral or interferon treatment naive at the time this study starts from 28 university affiliated hospital throughout China. |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 997 | ||||||||
| Completion Date | June 2011 | ||||||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01293279 | ||||||||
| Other Study ID Numbers ICMJE | CCgenos | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Lai Wei, Peking University People's Hospital | ||||||||
| Study Sponsor ICMJE | Peking University People's Hospital | ||||||||
| Collaborators ICMJE | Bristol-Myers Squibb | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Peking University People's Hospital | ||||||||
| Verification Date | June 2011 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||