Overview

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