Chronic Hepatitis CNCT00635310
Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-treated With Vasopressin
A study testing Percutaneous liver biopsy in people with Chronic Hepatitis C and Chronic Hepatitis B, run by National Taiwan University Hospital at 5 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Hepatitis C, Chronic Hepatitis B, Biopsy
- What is being tested?
- Percutaneous liver biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,520 participants
- Where
- 5 sitesTaiwan
- Study dates
- Jan 2005to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Recruiting
Chiayi Christian Hospital
Chiayi City
Peir-Haur Hung, MD
Peir-Haur Hung, MD
- Recruiting
St. Martin De Porres Hospital
Chiayi City
Hung-Bin Tsai, MD
Hung-Bin Tsai, MD
- Recruiting
National Taiwan University Hospital, Yun-Lin Branch
Douliu
Shih-Jer Hsu, MD
Shih-Jer Hsu, MD
- Recruiting
Far Eastern Memorial Hospital
Taipei, 100
Cheng-Chao Liang, MD
Cheng-Chao Liang, MD
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chen-Hua Liu, MD, +886-2-23123456 ext. 3572, jacque_liu@mail2000.com.tw
Chen-Hua Liu, MD
About this study
Official title: Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-treated With 1-Deamino-8- D-Arginine Vasopressin
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.
Read the detailed description
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.
- Conditions
- Chronic Hepatitis C, Chronic Hepatitis B, Biopsy, Hemodialysis
- Being tested
- Percutaneous liver biopsy
- Keywords
- Chronic hepatitis C, Chronic hepatitis B, Liver biopsy, Hemodialysis, 1-Deamino-8- D-Arginine Vasopressin
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous liver biopsyProcedure or surgery
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)
Percutaneous liver biopsyProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Percutaneous liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis
Measured: 14 days
Secondary outcomes (1)
Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJan 2005
- Primary completionJun 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chen-Hua Liu, MD, Principal investigator, National Taiwan University HospitalJia-Horng Kao, MD, Principal investigator, National Taiwan University HospitalChun-Jen Liu, MD, Principal investigator, National Taiwan University HospitalMing-Yang Lai, MD, Principal investigator, National Taiwan University HospitalPei-Jer Chen, MD, Principal investigator, National Taiwan University HospitalDing-Shinn Chen, MD, Principal investigator, National Taiwan University HospitalCheng-Chao Liang, MD, Principal investigator, Far Eastern Memorial HospitalShih-Jer Hsu, MD, Principal investigator, National Taiwan University Hospital, Yun-Lin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635310
- Sponsor's protocol ID
- 940211
- Status last verified
- Dec 2012
- First submitted
- 5 Mar 2008
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-treated With 1-Deamino-8- D-Arginine Vasopressin
- ClinicalTrials.gov ID
- NCT00635310
- Acronym / sponsor ID
- 940211
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,520 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2005
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD patients with CHC or CHB | Active comparator | Procedure: Percutaneous liver biopsyChronic 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) |
| Ordinary patients with CHC or CHB | Active comparator | Procedure: Percutaneous liver biopsyChronic hepatitis C (CHC) or chronic hepatitis B (CHB) patients with normal renal function (NRF) receiving percutaneous liver biopsies (PLBs) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous liver biopsyTwo 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) | Procedure or surgery | HD patients with CHC or CHB |
| Percutaneous liver biopsyTwo 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) | Procedure or surgery | Ordinary patients with CHC or CHB |
Primary outcome
Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis
Time frame: 14 days
1 secondary outcome
Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
Related trials for Chronic Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen-Hua Liu, MD principal investigator
National Taiwan University Hospital
Jia-Horng Kao, MD principal investigator
National Taiwan University Hospital
Chun-Jen Liu, MD principal investigator
National Taiwan University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous liver biopsy in people with Chronic Hepatitis C and Chronic Hepatitis B, run by National Taiwan University Hospital at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Hua Liu, MD (+886-2-23123456 ext. 3572, jacque_liu@mail2000.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.