EUCTR2015-001360-19-IT
Active, not recruiting
Phase 1
Prospective, phase II/III, randomized clinical study to compare BEGEDINA® versus conventional treatment for treating steroid resistant acute graft-versus host disease -
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- steroid resistant acute graft versus host disease
- Sponsor
- ADIENNE SA
- Enrollment
- 184
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \=18 and \=65 years of age.
- •2\. Recipient of an allogeneic hematopoietic stem cell
- •transplantation(HSCT).Note: Subjects with steroid resistant GvHD
- •following donor lymphocyte infusion post HSCT are also eligible
- •3\. Steroid\-resistant acute GvHD, Grade II\-IV, defined as:
- •\- progressive disease after 3 days of primary treatment with
- •methylprednisolone 2 mg/kg, or equivalent.
- •\- lack of at least a partial response after 7 days of primary treatment
- •with methylprednisolone 2 mg/kg or equivalent.
- •\- lack of a complete response after 14 days of primary treatment with
Exclusion Criteria
- •1\. Prior second\-line systemic treatment for GvHD.
- •2\. Received agents other than steroids for primary treatment of acute GvHD.
- •3\.Acute steroid resistant GvHD beyond 28 days from first\-line therapy (primary treatment).
- •4\.Stage 1\-2 skin acute GvHD alone (with no other organ involvement).
- •5\. Evidence of severe hepatic veno\-occlusive disease or sinusoidal obstruction.
- •6\. Evidence of encephalopathy.
- •7\. Life expectancy \<3 weeks.
- •8\. Presence of chronic GvHD
- •9\. Second or subsequent allogeneic transplant.
- •10\. Previous solid organ transplant (with the exception of a corneal transplant \>3 months prior to screening).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Untitled StudyEUCTR2015-001360-19-GBADIENNE SA36
Active, not recruiting
Phase 1
Untitled Studysteroid resistant acute graft versus host diseaseMedDRA version: 18.1 Level: PT Classification code 10066260 Term: Acute graft versus host disease System Organ Class: 10021428 - Immune system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]EUCTR2015-001360-19-FRADIENNE SA36
Active, not recruiting
Phase 1
Untitled StudySteroid resistant acute graft versus host disease.MedDRA version: 18.1Level: PTClassification code 10066260Term: Acute graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]EUCTR2015-001360-19-ESADIENNE SA184
Active, not recruiting
Phase 1
Untitled StudyEUCTR2015-001360-19-DEADIENNE SA36
Not yet recruiting
Phase 2
Study the effect of ayurvedic medicine on memory in children as well as elderly peopleCTRI/2017/08/009309Ayurved Sanshodhan Vibhag