Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with resistant oral cGvHD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Karnofsky >= 70

• Oral chronic GvHD after allogeneic haematopoietic stem cell transplantation

• Oral cGvHD of erosive and/or ulcerative type

• NIH scale >= 3

• Resistant oral cGvHD with no oral response to conventional primary treatment

Exclusion Criteria:

• Uncertain diagnosis of resistant oral cGvHD

• Symptomatic oral cGvHD of hyperkeratotic type solely

• Current active oral bacterial, viral, or fungal infection

• Unwilling to forego concurrent treatment for mucosal lesions and/or related oral pain

• Requiring addition of new systemic therapy including steroids, or radiation therapy

• Local intestinal infection

• Abnormal hepatic function or liver cirrhosis

• If careful medical monitoring is not ensured: tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection

• Second line treatment of oral cGvHD with topical steroids