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Secondary Prophylaxis of Gastrointestinal Bleeding in Cirrhotic Patients Using Thalidomide


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Hemorrhage, Portal Hypertension

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Trial Information

Secondary Prophylaxis of Gastrointestinal Bleeding in Cirrhotic Patients Using Thalidomide


Treatment duration with thalidomide will be for 16 weeks, beginning in the hospital setting
immediately after the index bleed, and clinical follow-up additional six months. Follow-up
in both the hepatology, outpatient clinic area and the endoscopy suite will occur. Step
wise thalidomide dosing will be 100 mg/d once a day at night. If no evidence of toxicity is
noted after 5 doses, the dose will be increased to 200 mg/d, and continued on that dose as
an outpatient until completion of the study protocol at 16 weeks. Patients will be followed
daily while inpatients, and subsequently at two-week intervals upon discharge. Females of
child-bearing potential will be seen weekly for the first month and must have a confirmed
negative pregnancy test prior to being dispensed the next one week supply of study drug.
After the first month, females of child-bearing potential will be seen every two weeks as
will all other subjects. Standard follow-up medical care after esophageal variceal bleeding
in patients who have undergone endoscopic therapy will include:

follow-up endoscopy at regular intervals until variceal obliteration, using either
endoscopic variceal ligation (EVL) or sclerotherapy titrated dose of a nonselective beta
blocker (propranolol).

At each follow-up visit, patients will be assessed for development of any interim outcome of
interest:

overt upper gastrointestinal bleeding need for transfusion worsening clinical status

Patients will initially be followed daily while hospitalized. outpatient visits will occur
every two-week intervals upon discharge. Standard follow-up medical care after esophageal
variceal bleeding in patients who have undergone endoscopic therapy will include:

follow-up endoscopy at regular intervals until variceal obliteration, using either
endoscopic variceal ligation (EVL) or sclerotherapy titrated dose of a nonselective beta
blocker (propranolol).

At each follow-up visit, patients will be assessed for development of any interim outcome of
interest:

overt upper gastrointestinal bleeding need for transfusion worsening clinical status the
need for TIPS, liver transplantation or death. In addition, patients and their families will
be questioned for any evidence of potential toxicity as assessed by using the CTC Toxicity
grade version 3, or adverse outcomes by one of the study investigators as well as a nurse
coordinator, using a standardized questionnaire along with a regular clinical


Inclusion Criteria:



- Endoscopic confirmation or portal hypertension related GI bleeding

- Over the age of 18 with the ability to willingly sign an informed consent

- Adequate performance status and cognitive ability

- Patients must be willing to comply with all FDA-mandated prescribing and safety while
taking Thalidomide

- Hemodynamically stable with no evidence of ongoing bleeding (defined as a Hgb that
has not varied by more than 10% over 12 hour period.)

Exclusion Criteria:

- No other serious illness or medical condition including unstable cardiac disease
requiring treatment, new onset crescendo or rest angina. Stable exertional angina is
acceptable.

- No history of significant neurological or psychiatric disorders including psychotic
disorders, dementia, or seizures or active infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

The proposed study would use a novel approach to prophylaxis, using thalidomide, an oral TNF inhibitor, in conjunction with a betablocker to prevent rebleeding of upper gastrointestinal bleeding in patients with cirrhosis and portal hyperte

Outcome Time Frame:

16 week duration

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

CEL-20237

NCT ID:

NCT00787436

Start Date:

May 2006

Completion Date:

October 2010

Related Keywords:

  • Gastrointestinal Hemorrhage
  • Portal Hypertension
  • portal hypertension
  • Gastroesophageal
  • Varices
  • Liver disease
  • cirrhosis
  • Gastrointestinal Hemorrhage
  • Hemorrhage
  • Hypertension
  • Hypertension, Portal

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195