Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-treated With Vasopressin

NCT00635310 | Unknown DMC

• 1 other identifier: 940211
• Study Type: interventional
• Target: 3,520
• Locations: 1 country
• Sites: 5

Brief Summary

Percutaneous liver biopsy (PLB) is the gold standard for grading necroinflammation and staging fibrosis in patients with chronic viral hepatitis. Whether the use of 1-deamino-8-D-arginine vasopressin (DDAVP) before PLBs in hemodialysis (HD) patients with chronic viral hepatitis has comparable safety profiles to those with normal renal function (NRF) has not been evaluated in prospective studies.

Conditions

Chronic Hepatitis C; Chronic Hepatitis B; Biopsy; Hemodialysis

Keywords

Chronic hepatitis C; Chronic hepatitis B; Liver biopsy; Hemodialysis; 1-Deamino-8- D-Arginine Vasopressin

Outcome Measures

Primary Outcomes (1)

• Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis

  14 days

Secondary Outcomes (1)

• Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis

  14 days

Study Arms (2)

HD patients with CHC or CHB

ACTIVE COMPARATOR

Chronic hepatitis C (CHC) or chronic hepatitis B (CHB) patients with hemodialysis (HD), pretreated with DDAVP 0.3 ug/kg body weight infusion 30-60 minutes before percutaneous liver biopsies (PLBs)

Procedure: Percutaneous liver biopsy

Ordinary patients with CHC or CHB

ACTIVE COMPARATOR

Chronic hepatitis C (CHC) or chronic hepatitis B (CHB) patients with normal renal function (NRF) receiving percutaneous liver biopsies (PLBs)

Procedure: Percutaneous liver biopsy

Interventions

Percutaneous liver biopsy PROCEDURE

Two passes of PLB from the right hepatic lobe by US guidance (ToshibaTM PLF-308P, Toshiba Co. Ltd., Tokyo, Japan) and 16-gauge automatic cutting needles (Temno EvolutionTM, Allegiance, McGaw Park, IL, USA)

HD patients with CHC or CHB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C (presence of anti-HCV and serum HCV RNA \> 6 months)
• Chronic hepatitis B (presence of HBsAg \> 6 months)
• Receiving regular hemodialysis or normal renal function (Creatinine \< 1.5 x ULN)
• Receiving percutaneous liver biopsy (PLB)

You may not qualify if:

• Human immunodeficiency virus (HIV) co-infection
• Unwilling or contraindicated to receive percutaneous liver biopsy (PLB)
• Receiving liver biopsy without ultrasound (US) guidance or automatic cutting needles
• Did not receive 2 passes of liver biopsy
• Inadequate record of post-biopsy complications

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (5)

Chiayi Christian Hospital

Chiayi City, Taiwan

RECRUITING

St. Martin De Porres Hospital

Chiayi City, Taiwan

RECRUITING

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

RECRUITING

Far Eastern Memorial Hospital

Taipei, 100, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis B, Chronic

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; Hepatitis B; Hepadnaviridae Infections; DNA Virus Infections

Study Officials

• Chen-Hua Liu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Jia-Horng Kao, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Chun-Jen Liu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Ming-Yang Lai, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Pei-Jer Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Ding-Shinn Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Cheng-Chao Liang, MD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Shih-Jer Hsu, MD

  National Taiwan University Hospital, Yun-Lin Branch

  PRINCIPAL INVESTIGATOR

• Jou-Wei Lin, MD

  National Taiwan University Hospital, Yun-Lin Branch

  PRINCIPAL INVESTIGATOR

• Shih-I Chen, MD

  National Taiwan University Hospital, Yun-Lin Branch

  PRINCIPAL INVESTIGATOR

• Hung-Bin Tsai, MD

  St. Martin De Porres Hospital

  PRINCIPAL INVESTIGATOR

• Peir-Haur Hung, MD

  Chiayi Christian Hospital

  PRINCIPAL INVESTIGATOR

• Jun-Herng Chen, MD

  National Taiwan University Hospital, Yun-Lin Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Hua Liu, MD

CONTACT

+886-2-23123456; jacque_liu@mail2000.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Study Start: January 1, 2005
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

TW (5)