## Protocol Section
### Identification Module
**NCT ID:** NCT01293279

**Acronym:** HCV

**Brief Title:** HCV (Hepatitis C Virus) Viral and Host Genotyping (IL28B, Interleukin 28B) in China

**Official Title:** HCV Viral Genotyping Distribution and Genetic Variation in IL28B Distributions Among the Han Ethnic Chinese in China

#### Organization Study ID Info
**ID:** CCgenos
#### Organization
**Class:** OTHER
**Full Name:** Peking University People's Hospital
### Status Module
#### Completion Date
**Date:** 2011-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-10-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-10-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-06

**Type:** ACTUAL

#### Start Date
**Date:** 2011-02

**Status Verified Date:** 2011-06

#### Study First Post Date
**Date:** 2011-02-10
**Type:** ESTIMATED
**Study First Submit Date:** 2011-02-09
**Study First Submit QC Date:** 2011-02-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking University People's Hospital

#### Responsible Party

**Investigator Affiliation:** Peking University People's Hospital

**Investigator Full Name:** Lai Wei

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hepatitis C

**Keywords:**

- HCV viral genotypes

- host genotypes

- IL28B

- ITPA

- RNA

- China

### Design Module

#### Bio Spec

**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

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 997

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Label:** HCV Patients who are treatment naive

### Outcomes Module

#### Primary Outcomes

**Description:** To describe the distributions of both HCV viral and host genotypes (IL28B and ITPA) among antiviral treatment naive HCV patients

**Measure:** Hepatitis C viral and host genotypes

**Time Frame:** Confirmation of an HCV infection 30 days prior to the recruitment

#### Secondary Outcomes

**Description:** To describe the distribution of HCV RNA levels in antiviral treatment-naive HCV patients

**Measure:** Hepatitis C RNA levels

**Time Frame:** Confirmation of an HCV infection 30 days prior to the recruitment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* male or female
* Han ethnic
* ≥ 18 years old
* recent confirmation of anti-HCV-antibody positive and HCV RNA positive 30 days prior to the recruitment
* antiviral or interferon treatment naive

Exclusion Criteria:

* \< 18 years old
* not Han ethnic
* treated by antiviral before this study

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** 1000 Han ethnic Chinese in China

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** Lai Wei

**State:** Beijing

**Zip:** 100044

#### Overall Officials

**Official 1:**

**Affiliation:** Peking University People's Hospital, Peking University Hepatology Institute

**Name:** Lai Wei, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Hong Li, Ph.D., MPH

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Wu N, Rao HY, Yang WB, Gao ZL, Yang RF, Fei R, Gao YH, Jin Q, Wei L. Impact of hepatitis C virus genotype 3 on liver disease progression in a Chinese national cohort. Chin Med J (Engl). 2020 Feb 5;133(3):253-261. doi: 10.1097/CM9.0000000000000629.

**PMID:** 31934936

**Citation:** Huang R, Rao H, Shang J, Chen H, Li J, Xie Q, Gao Z, Wang L, Wei J, Jiang J, Sun J, Jiang J, Wei L. A cross-sectional assessment of health-related quality of life in Chinese patients with chronic hepatitis c virus infection with EQ-5D. Health Qual Life Outcomes. 2018 Jun 15;16(1):124. doi: 10.1186/s12955-018-0941-8.

**PMID:** 29903024

**Citation:** Yan LB, Rao HY, Ma YJ, Bai L, Chen EQ, Du LY, Yang RF, Wei L, Tang H; CCgenos Study Group. Hepatitis B virus infection in Chinese patients with hepatitis C virus infection: prevalence, clinical characteristics, viral interactions and host genotypes: a nationwide cross-sectional study. BMJ Open. 2016 Oct 12;6(10):e012016. doi: 10.1136/bmjopen-2016-012016.

**PMID:** 27733412

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018178

- Term: Flaviviridae Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006526

- Term: Hepatitis C

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M20971

- Name: Hepatitis C Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10407

- Name: Interferons

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
