Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-treated With Vasopressin
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ClinicalTrials.gov Identifier: NCT00635310 |
Recruitment Status
: Unknown
Verified December 2012 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted
: March 13, 2008
Last Update Posted
: December 20, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis C Chronic Hepatitis B Biopsy Hemodialysis | Procedure: Percutaneous liver biopsy | Not Applicable |
Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and annual incidence of 3-80% and 2.9%, respectively. Currently, percutaneous liver biopsy (PLB) remains the gold standard for grading necroinflammation and staging fibrosis in patients with liver diseases. In addition, liver histology can help clinicians determine the eligibility of renal transplantation, prognosis, and necessity of antiviral therapy in dialysis patients with chronic viral hepatitis. In chronic hepatitis patients with normal renal function (NRF), the risks of fatal and non-fatal hemorrhage after liver biopsies for non-malignant diseases were 0.04% and 0.16%, respectively. However, the relative risks of post-biopsy hemorrhage in CHC patients with end-stage renal disease to those with NRF remain disputed.
Deamino-8-D-arginine vasopressin (DDAVP), a synthetic analogue of vasopressin, is a commonly used hemostatic agent to treat uremic bleeding by inducing the release of von Willebrand factor (vWF) and factor VIII from their storage sites in endothelial cells.Previous studies have shown that one dose of 0.3-0.4μg/kg body weight DDAVP infusion for dialysis patients could normalize bleeding time (BT), and prevent surgical and renal biopsy bleeding. Nevertheless, two recent studies showed divergent liver biopsy-related bleeding complication rates (0% and 6%, respectively) in dialysis CHC patients pre-treated with DDAVP. Since most studies evaluating the safety of PLB in CHC patients with dialysis were small and retrospective in nature, and not controlled by the biopsy route, the type of biopsy needle, the use of ultrasound guidance, or the number of passes,further studies are urgently needed to solve this important issue. Thus, we aimed to conducted a large clinical trial to compare the safety profiles of PLB between CHC patients with hemodialysis (HD) who were pretreated with DDAVP and those with NRF by the same biopsy technique.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 3520 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-treated With 1-Deamino-8- D-Arginine Vasopressin |
Study Start Date : | January 2005 |
Estimated Primary Completion Date : | June 2013 |
Estimated Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: HD patients with CHC or CHB
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)
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Procedure: Percutaneous liver biopsy
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)
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Active Comparator: Ordinary patients with CHC or CHB
Chronic hepatitis C (CHC) or chronic hepatitis B (CHB) patients with normal renal function (NRF) receiving percutaneous liver biopsies (PLBs)
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Procedure: Percutaneous liver biopsy
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)
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- Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis [ Time Frame: 14 days ]
- Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis [ Time Frame: 14 days ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635310
Contact: Chen-Hua Liu, MD | +886-2-23123456 ext 3572 | jacque_liu@mail2000.com.tw |
Taiwan | |
Chiayi Christian Hospital | Recruiting |
Chia-Yi, Taiwan | |
Contact: Peir-Haur Hung, MD | |
Principal Investigator: Peir-Haur Hung, MD | |
St. Martin De Porres Hospital | Recruiting |
Chia-Yi, Taiwan | |
Contact: Hung-Bin Tsai, MD | |
Principal Investigator: Hung-Bin Tsai, MD | |
National Taiwan University Hospital, Yun-Lin Branch | Recruiting |
Douliou, Taiwan | |
Contact: Shih-Jer Hsu, MD | |
Principal Investigator: Shih-Jer Hsu, MD | |
Principal Investigator: Jou-Wei Lin, MD | |
Principal Investigator: Shih-I Chen, MD | |
Principal Investigator: Jun-Herng Chen, MD | |
Far Eastern Memorial Hospital | Recruiting |
Taipei, Taiwan, 100 | |
Contact: Cheng-Chao Liang, MD | |
Principal Investigator: Cheng-Chao Liang, MD | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 100 | |
Contact: Chen-Hua Liu, MD +886-2-23123456 ext 3572 jacque_liu@mail2000.com.tw | |
Principal Investigator: Chen-Hua Liu, MD | |
Principal Investigator: Jia-Horng Kao, MD | |
Principal Investigator: Chun-Jen Liu, MD | |
Principal Investigator: Ming-Yang Lai, MD | |
Principal Investigator: Pei-Jer Chen, MD | |
Principal Investigator: Ding-Shinn Chen, MD |
Principal Investigator: | 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 |
Responsible Party: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00635310 History of Changes |
Other Study ID Numbers: |
940211 |
First Posted: | March 13, 2008 Key Record Dates |
Last Update Posted: | December 20, 2012 |
Last Verified: | December 2012 |
Keywords provided by National Taiwan University Hospital:
Chronic hepatitis C Chronic hepatitis B Liver biopsy Hemodialysis 1-Deamino-8- D-Arginine Vasopressin |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis B Hepatitis C, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Hepadnaviridae Infections DNA Virus Infections Liver Extracts Vasopressins Arginine Vasopressin Deamino Arginine Vasopressin Hematinics Hemostatics Coagulants Vasoconstrictor Agents Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |