Prediction of Significant Hepatic Fibrosis in HCV Carriers With PNALT by SAPI- A Validation Study

NCT00466271 | Completed DMC

• 1 other identifier: 200611011R
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to validate the diagnostic accuracy and reproducibility of SAPI to predict significant hepatic fibrosis in HCV patients with PNALT who are scheduled to receive combination therapy with pegylated interferon plus ribavirin and percutaneous liver biopsies.

Conditions

Chronic Hepatitis C; Hepatic Fibrosis

Keywords

Chronic hepatitis C; Persistently normal alanine aminotransferase levels; Hepatic fibrosis; Non-invasive diagnosis; Splenic arterial pulsatility index

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HCV carriers with persistently normal ALT levels who will receive percutaneous liver biopsy

You may qualify if:

• Age older than 18 years
• HCV RNA and anti-HCV positivity for more than 6 months
• consecutive normal ALT values (\< 40 IU/L for men and \< 34 IU/L for women)at 3 months apart over a period of 12 months

You may not qualify if:

• HBV and HCV co-infection
• HBV and HIV co-infection
• History of heavy alcohol use (\> 50 gram/day)
• Autoimmune liver diseases
• Metabolic liver diseases
• Presence of hepatocellular carcinoma
• Bleeding tendency
• Decline liver biopsies

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (31)

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MeSH Terms

Conditions

Hepatitis C, Chronic; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Officials

• Chen-Hua Liu, MD

  Department of Internal Medicine, National Taiwan Universitys Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2007
• First Posted: April 27, 2007
• Study Start: April 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 23, 2008

Record last verified: 2008-12

Locations

TW (1)