Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-treated With 1-Deamino-8- D-Arginine Vasopressin
Sponsor study identifier
interventional
3,520
1 country
5
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 5, 2008
Actual (reported)March 13, 2008
Actual (reported)June 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis
14 days
Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis
14 days
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)
Chronic hepatitis C (CHC) or chronic hepatitis B (CHB) patients with normal renal function (NRF) receiving percutaneous liver biopsies (PLBs)
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)
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)
Chiayi Christian Hospital
Chiayi City, Taiwan
St. Martin De Porres Hospital
Chiayi City, Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Chen-Hua Liu, MD
National Taiwan University Hospital
Jia-Horng Kao, MD
National Taiwan University Hospital
Chun-Jen Liu, MD
National Taiwan University Hospital
Ming-Yang Lai, MD
National Taiwan University Hospital
First Submitted
March 5, 2008
First Posted
March 13, 2008
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Estimated (date passed)EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Douliu, Taiwan
Far Eastern Memorial Hospital
Taipei, 100, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Pei-Jer Chen, MD
National Taiwan University Hospital
Ding-Shinn Chen, MD
National Taiwan University Hospital
Cheng-Chao Liang, MD
Far Eastern Memorial Hospital
Shih-Jer Hsu, MD
National Taiwan University Hospital, Yun-Lin Branch
Jou-Wei Lin, MD
National Taiwan University Hospital, Yun-Lin Branch
Shih-I Chen, MD
National Taiwan University Hospital, Yun-Lin Branch
Hung-Bin Tsai, MD
St. Martin De Porres Hospital
Peir-Haur Hung, MD
Chiayi Christian Hospital
Jun-Herng Chen, MD
National Taiwan University Hospital, Yun-Lin Branch
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 20, 2012
Record last verified: 2012-12
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