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To Evaluate the Efficacy and Safety of Rapamycin for Crohn's Disease-related Stricture

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ClinicalTrials.gov Identifier: NCT02675153
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Brief Summary:
Crohn's disease (CD) with stenosis has limited therapeutic options and with high surgical rate. The present clinical trial aims to evaluate the efficacy and safety of rapamycin in the treatment of stricturing Crohn's Disease.

Condition or disease Intervention/treatment Phase
Crohn's Diseases Drug: Rapamycin Not Applicable

Detailed Description:
Management of Crohn's disease (CD) with stenosis is challenging and often requires endoscopic dilatation or surgical resection of the strictured bowel. Sirolimus (rapamycin), a macrocyclic antibiotic with immunosuppressive and antineoplastic properties, has been reported as promising rescue therapy for refractory CD. This study aims to evaluate the use of sirolimus for stricturing Crohn's Disease. Patients in this study will receive a continuous dosing schedule of oral sirolimus 2mg daily for six months. Clinical responses were defined as the ability to tolerate the regular diet with vegetable fiber combined with a reduction of ≥ 75% in overall target score and a score of less than two points for each item.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Rapamycin in the Treatment of Crohn's Disease-related Stricture
Actual Study Start Date : April 1, 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Upper gastrointestinal strictures
Patients with upper gastrointestinal strictures were treated with rapamycin (2mg/day, Sirolimus, Roche) for at least six months.
Drug: Rapamycin
Participants with gastrointestinal strictures were treated with rapamycin 2mg daily at least six months.
Other Name: Sirolimus

Experimental: Lower gastrointestinal strictures
Patients with lower gastrointestinal strictures were treated with rapamycin (2mg/day, Sirolimus, Roche) for at least six months.
Drug: Rapamycin
Participants with gastrointestinal strictures were treated with rapamycin 2mg daily at least six months.
Other Name: Sirolimus




Primary Outcome Measures :
  1. Response rate [ Time Frame: up to 24 weeks ]
    Response was defined as the following criteria: (a) the ability to tolerate a normal diet (vegetable fiber), with a reduction of ≥ 75% in overall baseline target score and sub-score ≤ 2 (Table S1); (b) no need for ED or surgery; (c) no severe adverse events or any other reasons leading to rapamycin withdrawal.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: through study completion, an average of 3 years ]
    New onset of symptoms and the exacerbation of previous symptoms were recorded as adverse events (AEs)

  2. The rate of surgery or ED after rapamycin [ Time Frame: through study completion, an average of 3 years ]
    For long-term treatment outcomes, the primary endpoint was the rate of surgery or ED after rapamycin.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chinese patients (≥18 years of age) with a documented definite diagnosis of CD;
  2. the presence of a clinically symptomatic stricture;
  3. strictures confirmed by endoscopy (passage of the endoscope with resistance or not traversable) or imaging (CT enterography (CTE) or MR enterography (MRE).

Exclusion Criteria:

  1. Patients who were pregnant, diagnosed with intestinal perforation, complete intestinal obstruction, any signs of dysplasia or malignancy, or use of anti-tumor necrosis factor (TNF) in the last three months;
  2. Patients who were not followed up between the inception of medication and any other subsequent treatments.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675153


Contacts
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Contact: Faming Zhang, MD,PhD 086-25-58509883 fzhang@njmu.edu.cn

Locations
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China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, MD, PhD    086-25-58509883    fzhang@njmu.edu.cn   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Investigators
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Principal Investigator: Faming Zhang, MD,PhD The Second Hospital of Nanjing Medical University
Publications:
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Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02675153    
Other Study ID Numbers: RAPA-CN-160122
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
rapamycin
stricture
fibrosis
Additional relevant MeSH terms:
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Crohn Disease
Constriction, Pathologic
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs