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Safety and Tolerability of Vorinostat for the Treatment of Moderate-to-Severe Crohn’s Disease

September 12, 2019

Overview

Since the inflammatory bowel disease of Crohn’s disease has no cure, researchers are always attempting to uncover better treatment options. This clinical trial involves researching whether the medicine vorinostat is safe to treat people with moderate to severe Crohn’s disease.

 

Study Information

Researchers are studying the safety and efficacy of vorinostat, 100mg given twice a day for 12 weeks, in treating 20 individuals with Crohn’s disease. The effectiveness of vorinostat will be determined through changes in symptom scores, endoscopic/histologic findings, and immunologic/laboratory parameters. The participant will return to the NIH CC after starting treatment on Days 28, 56 and Week 12 for assessing safety and testing of clinical and immunologic response. They will return again 6 and 9 months after treatment.

 

Inclusion Criteria

  • All sexes 18 to 65 years old
  • Diagnosed with Crohn’s Disease
  • Have active Crohn’s symptoms like continued weight loss, abdominal pain, and/or diarrhea
  • The participant must have active CD symptoms and no response to at least 1 of the following agent groups: 
    • Corticosteroids or Immunomodulators
    • TNF-alpha sign antagonists 
    • Anti-integrin antibodies. 
    • At the discretion of the Principal Investigator, concomitant medications will be permitted in certain conditions
  • Agree to have samples of their blood and tissue stored for potential future research use.
  • Participants must have a primary medical care provider.
  • Male participants must agree to use birth control measures to prevent pregnancy in female partners from start of treatment, and continuing to use for 8 weeks after treatment.
  • Not pregnant or breast-feeding
  • Not engaged in unprotected intercourse for one month before trial
  • Agree to remain completely abstinent of potentially reproductive sexual intercourse or to consistently use a male or female condom with spermicide AND ALSO one of the below listed birth control methods:
    • Continuous/daily hormonal methods including oral contraceptive pills, patch, implant/injection, etc.
    • Surgical sterilization of either partner and NOT known to have failed.
    • Intrauterine device.

 

Exclusion Criteria

  • Presence of clinically significant systemic infection within three months of screening.
  • History or presence of recurrent or chronic infection
  • Positive for tuberculosis via PPD or QFT-G
  • A conduction abnormality on baseline electrocardiogram (ECG) that in the opinion of a cardiologist, is deemed significant.
  • At the discretion of the investigator, off-label use of any small molecule therapeutics that are immune modulators (e.g., naltrexone) within 90 days of beginning screening or at any time during the 30 days of the screening window.
  • Presence of abnormal hematological and biochemical parameters, including:
    • Neutrophil count < 1500 cells/mm3.
    • Hemoglobin < 9 g/dL.
    • Platelet count less than or equal to 150,000 cells/mm3.
    • Creatinine greater than or equal to 1.2 times the upper limit of normal (ULN).
    • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than or equal to 1.5 times ULN.
    • Prothrombin time-international normalized ratio (PT-INR) > 1.0 ULN
    • Serum bilirubin level > 1.0 times ULN.
  • Individuals on chronic anticoagulation medications.
  • Stool sample for GI pathogens. If a stool sample determined positive for acute gastrointestinal infection with impact of occurrence on gastrointestinal inflammation as determined by the principal investigator during screening. In addition, stool samples positive for GI pathogens will be discussed with an infectious disease physician to determine impact of occurrence on gastrointestinal inflammation. If the organism is thought to be pathogenic the patient will receive appropriate treatment. This will be documented in the participant’s medical record.
  • Presence of cytomegalovirus (CMV) infection.
  • History of low-grade or high-grade colonic mucosal dysplasia.
  • History of bowel surgery other than perianal (e.g., fistulotomy, seton placement, or abscess drainage) within 6 months prior to beginning the CDAI screening diary or drawing screening blood samples.
  • Presence of surgical changes to gut anatomy that preclude administration of clinical activity indices; this includes but is not limited to ileostomy, colostomy, or subtotal colectomy with ileorectal anastomosis.
  • Known or suspected short bowel syndrome.
  • Requirement of parenteral, total parenteral, elemental oral, or nasogastric nutrition.
  • History of cancer, other than non-melanomatous cancer of the skin, within the past 5 years.
  • Unwillingness or inability to comply with study requirements.
  • Presence of only small bowel CD that is inaccessible by standard colonoscopy for harvest of research biopsies. Individuals with only upper gastrointestinal CD or only perianal fistulizing CD are also excluded for this reason.
  • Refusal to abstain from using COX-2 inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) throughout the study agent administration period.
  • Has uncontrolled diabetes
  • Is taking anti-seizure medication, such as valproic acid or its derivative (i.e., Depakote)
  • Presence of any condition that, in the opinion of the investigator, contraindicates participation in this study.
  • Has participated in another investigational trial within 8 weeks (or 5 half-lives of any investigational study agent), whichever is greater, prior to the pre-trial (screening) visit. The window will be derived from the last date of treatment on the previous trial.

 

Locations

You may participate in this study at the National Institutes of Health Clinical Center in Bethesda, Maryland, United States, 20892. If you have any questions or concerns, please feel free to contact Ivan J Fuss, M.D. at 301-496-9662 or at ifuss@niaid.nih.gov. You may also contact the NIH Clinical Center contact Office of Patient Recruitment (OPR) at 800-411-1222 ext TTY8664111010 or at  prpl@cc.nih.gov.

 

Sponsors/Collaborators

This clinical trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) with Ivan J Fuss, M.D. as the Principal Investigator.

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