Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study Summary
The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal acute graft versus host disease (aGVHD).
Eligible Conditions
- GVHD
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 10 Secondary · Reporting Duration: Baseline to 2 years
Day 14
Lower gastrointestinal-aGVHD response
Day 14
Overall response
Baseline to 2 years
Failure free survival post-first dose of apraglutide
Graft failure post-first dose of apraglutide
Lower Gastrointestinal-GVHD relapse following complete GI response
Malignancy relapse/progression post-first dose of apraglutide
Overall survival post-first dose of apraglutide
Day 56
Absorption rate constant (ka) of apraglutide through population PK data analysis
Apparent clearance (CL/F) of apraglutide through population PK data analysis
Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis
Week 104
Adverse events (AE)
Occurrence and titer anti-drug antibodies (ADA)
Occurrence of clinically relevant changes in electrocardiogram
Occurrence of clinically relevant changes in vital signs
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
3 Treatment Groups
Apraglutide Low Dose
1 of 3
Apraglutide High Dose
1 of 3
Apraglutide open label
1 of 3
Experimental Treatment
34 Total Participants · 3 Treatment Groups
Primary Treatment: Apraglutide · No Placebo Group · Phase 2
Apraglutide Low Dose
Drug
Experimental Group · 1 Intervention: Apraglutide · Intervention Types: DrugApraglutide High Dose
Drug
Experimental Group · 1 Intervention: Apraglutide · Intervention Types: DrugApraglutide open label
Drug
Experimental Group · 1 Intervention: Apraglutide · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apraglutide
2020
Completed Phase 1
~20
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 2 years
Closest Location: South Austin Medical Center · Austin, TX
N/AFirst Recorded Clinical Trial
1 TrialsResearching GVHD
0 CompletedClinical Trials
Who is running the clinical trial?
VectivBio AGLead Sponsor
7 Previous Clinical Trials
324 Total Patients Enrolled
AdelmannStudy DirectorVectivBio AG
Eligibility Criteria
Age Any Age · All Participants · 8 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are at least 12 years of age and weigh at least 40 kg.
You are able to give informed consent and agree to follow the details of participation as outlined in the protocol.
You are a woman of childbearing potential (WOCBP).
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments