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Esophageal VaricesPhase 3NCT00331188

Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding

A Phase 3 study testing Sanvar® (vapreotide) in people with Esophageal Varices and Portal Hypertension, run by Debiovision at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this study is to determine the efficacy of early administration of Sanvar® in combination with endoscopic treatment for the control of acute variceal bleeding. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Sanvar® (vapreotide)
How many people
70 participants
Where
19 sitesUnited States
Study dates
May 2006to Jul 2008
Phase
Phase 3
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or male cirrhotic patient aged 18 to 75 years.
  • Hematemesis and/or melena (suspected to be caused by portal hypertension)
  • Time interval <=24 hours between onset of initial hemorrhage and initiation of study drug infusion.
  • Time interval <=6 hours between admission and initiation of study drug infusion.
  • Anticipated time interval<=12 hours between admission and end of therapeutic endoscopy.
  • Unequivocal history of cirrhosis, either documented by at least one of classical clinical signs (abdominal collateral venous circulation, firm liver with a sharp lower liver edge, presence of spider naevi, and/or ascites), or by biochemical and/or Doppler-US signs.
  • Written informed consent obtained by the patient or his/her relative(s)

Who cannot join

  • Patient previously included in this study for a prior bleeding episode.
  • Patients treated with a vasoactive drug such as octreotide, vasopressin or its analogue for the current episode of bleeding.
  • Hepatic encephalopathy Grade IV.
  • Balloon tamponade already positioned at admission.
  • Known Child-Pugh score >=13
  • Pregnant or breast-feeding women.
Show all 15Show fewer
  • Known diffuse hepatocellular carcinoma.
  • Known complete portal venous thrombosis.
  • Bleeding from esophageal varices within the previous 6 weeks.
  • Patient currently enrolled in another therapeutic study, and/or who participated in another clinical study, within the previous 6 weeks.
  • Known allergy to somatostatin or somatostatin analogues.
  • Previous porto-systemic shunt (TIPS) or orthotopic liver transplantation.
  • Patient with known cancer.
  • Patient with known chronic renal failure (serum creatinine > 1.5 mg/dl).
  • Severe concomitant disease judged by the Investigator as being incompatible with evaluation of treatment.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Mission Hospitals, Inc.

    Asheville, North Carolina, 28801

  • Johns Hopkins Hospital & School of Medicine, Div. of Gastroenterology & Hepatology

    Baltimore, Maryland, 21205

  • UAB Liver Center

    Birmingham, Alabama, 35294-0005

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University, The Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Colorado Health Sciences Center

    Denver, Colorado, 80262

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Alabama Liver & Digestive Specialists

    Montgomery, Alabama, 36116

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Virginia Commonwealth University MCV Campus West Hospital

    Richmond, Virginia, 23298

  • CHRISTUS Santa Rosa Medical Center

    San Antonio, Texas, 78229

  • University of California at San Diego

    San Diego, California, 92103-8707

  • Mayo Clinic

    Scottsdale, Arizona, 85054

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: The Early Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding Due to Portal Hypertension

The main objective of this study is to determine the efficacy of early administration of Sanvar® in combination with endoscopic treatment for the control of acute variceal bleeding.

Read the detailed description

This is a single-arm open-label clinical study with historical controls using Sanvar® (vapreotide) administered for 5 days in patients with acute variceal bleeding due to portal hypertension.

Cirrhotic patients with a history of acute hematemesis and/or melena admitted to the emergency unit and meeting the eligibility criteria will receive, as soon as possible after admission (within a maximum of 24 hours after onset of hemorrhage and within 6 hours after admission), Sanvar® (vapreotide acetate) 50 µg IV bolus followed by an IV continuous infusion of 50 µg/h for 5 days.

The diagnostic and therapeutic endoscopy will be performed as soon as possible after the initiation of the study drug infusion, but no more than 12 hours after the patient's admission to the study center. A final follow up will be performed on Day 42.

Patients for whom the source of bleeding is determined at endoscopy to be due to a cause other than portal hypertension (e.g. gastric ulcer) will be replaced. In addition, in such cases the study medication will be discontinued and patients will receive standard treatment according to the cause of their bleeding. These patients will be followed up for safety only.

*Note: There is no provision in this study to have an expanded access program.

Being tested
Sanvar® (vapreotide)
Keywords
Esophageal Variceal Bleeding, Portal Hypertension, Hepatic Cirrhosis, Cirrhosis, Liver Cirrhosis, Somatostatin Analog, Vapreotide, Acute Esophageal Variceal Bleeding
Medical subject headings
Esophageal and Gastric Varices, Hypertension, Portal, Liver Cirrhosis, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sanvar® (vapreotide)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the efficacy of the early administration of Sanvar® (vapreotide) in association with endoscopic treatment for the control of bleeding at 5 days, i.e. control of initial bleeding and prevention of early re-bleeding, plus survival.

    Measured: 5 days

Secondary outcomes (6)

  1. To assess the following:

  2. The effect of drug administration before endoscopy assessed by the endoscopic facilitation and control of bleeding at endoscopy,

    Measured: Endoscopy

  3. Control of bleeding 6 hours after infusion of the study drug (= Tinf + 6h),

    Measured: Tinf + 6h

  4. Control of bleeding by time periods (Tendo+6h, Tendo+48h and Tendo+ 120h) by Child Pugh class,

    Measured: Tendo+6h, Tendo+48h and Tendo+ 120h

  5. Number of blood units administered during the 5 days of drug infusion,

    Measured: 5 days

  6. Safety of treatment

    Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJun 2008
  4. Study completionJul 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00331188
Sponsor's protocol ID
DEBV-VAP/EVB-301
Status last verified
Jul 2008
First submitted
26 May 2006
Last updated
8 Jul 2008
Results posted
No
Data monitoring committee
No

Publications

  • Cales P, Masliah C, Bernard B, Garnier PP, Silvain C, Szostak-Talbodec N, Bronowicki JP, Ribard D, Botta-Fridlund D, Hillon P, Besseghir K, Lebrec D; French Club for the Study of Portal Hypertension. Early administration of vapreotide for variceal bleeding in patients with cirrhosis. N Engl J Med. 2001 Jan 4;344(1):23-8. doi: 10.1056/NEJM200101043440104.

    PubMed 11136956

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sanvar® (vapreotide) in people with Esophageal Varices and Portal Hypertension, run by Debiovision at 19 sites in United States.

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 7 inclusion and 15 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: finished, as of the sponsor's last update on 8 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the efficacy of the early administration of Sanvar® (vapreotide) in association with endoscopic treatment for the control of bleeding at 5 days, i.e. control of initial bleeding and prevention of early re-bleeding, plus survival. (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00331188, which also lists 1 linked publication.

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 8 Jul 2008.

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