Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03824795|
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Drug: MGB-BP-3||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||This is an open-label study with 3 sequential groups of 10 patients with CDAD with a staggered start.|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory, Open Labelled, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With Clostridium Difficile-associated Diarrhea (CDAD)|
|Actual Study Start Date :||February 7, 2019|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||October 2019|
Active Comparator: Group 1: 125mg b.i.d. for 10 days
Patients will be administered an oral dose of 125mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
Active Comparator: Group 2: 250mg b.i.d. for 10 days
Patients will be administered an oral dose of 250mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
Active Comparator: Group 3: 500mg b.i.d. for 10 days
Patients will be administered an oral dose of 500mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
- Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0. [ Time Frame: 40 days ]Incidence of treatment emergent adverse events (Safety and Tolerability of up to 3 incremental doses of MGB-BP-3 in patients with CDAD).
- Initial cure rate at 12 days post initiation of therapy. [ Time Frame: 12 days ]Initial clinical cure is defined as resolution of diarrhea (<3 bowel movements with unformed stools within 24 hours [Type 5, 6, or 7 bowel movement on the Bristol Stool Chart] for patients for 2 consecutive days), maintained for the subsequent duration of therapy (1 day of exacerbation and then return to the resolved state is acceptable), with no further requirement for CDAD therapy, assessed by EOT and sustained for 2 days after the end of the 10-day initial treatment course.
- CDAD Recurrence [ Time Frame: Up to 8 weeks ]Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.
- Peak plasma concentration (Cmax). [ Time Frame: 10 days ]Days 1, 5 and 10.
- Time to peak plasma concentration (Tmax). [ Time Frame: 10 days ]Days 1, 5 and 10.
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): NCT03824795
|Contact: Syneos Health|
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27604|
|Contact: Brittania O'Brien 919-926-6278 email@example.com|