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Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD

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ClinicalTrials.gov Identifier: NCT03824795
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
MGB Biopharma Limited

Brief Summary:
The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: MGB-BP-3 Phase 2

Detailed Description:
This is an exploratory, Phase IIa, open-label study assessing the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 with 3 sequential groups of 10 patients with CDAD. Patients will be administered an oral dose of MGB-BP-3 for 10 days (Day 1 to Day 10). At the end of the treatment period, patients will be followed for up to 8 weeks to assess the incidence of disease recurrence.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
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).
Drug: MGB-BP-3
MGB-BP-3

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).
Drug: MGB-BP-3
MGB-BP-3

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).
Drug: MGB-BP-3
MGB-BP-3




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. CDAD Recurrence [ Time Frame: Up to 8 weeks ]
    Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.

  2. Peak plasma concentration (Cmax). [ Time Frame: 10 days ]
    Days 1, 5 and 10.

  3. Time to peak plasma concentration (Tmax). [ Time Frame: 10 days ]
    Days 1, 5 and 10.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Age 18 years or older of any gender.
  2. Inpatients and/or outpatients who are able to attend all scheduled visits.
  3. Patients with the first episode or the first recurrence of mild or moderate CDAD.
  4. Confirmed diagnosis of mild or moderate CDAD as defined by the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines.

Main Exclusion Criteria:

  1. Patients with severe complicated CDAD (including hypotension or shock, ileus, megacolon, pseudomembranous colitis).
  2. A white blood cell count higher than 15,000 cells/mL.
  3. A serum creatinine level greater than or equal to 1.5 times ULN.
  4. Elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater than ULN.
  5. Inflammatory bowel disease (ulcerative colitis or Crohn's disease), microscopic colitis, or irritable bowel syndrome with chronic diarrhea.
  6. Any other non-C difficile diarrhea.
  7. Received treatment with a fecal transplant within 7 days and/or is anticipated to receive a fecal transplant during the study.
  8. Major gastrointestinal surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).
  9. Received laxatives within the previous 48 hours.
  10. Pregnant or lactating women.
  11. Prior (within 180 days of Screening) or current use of anti-toxin antibodies.
  12. Have received a vaccine against C difficile.
  13. Any condition for which, in the opinion of the investigator, the treatment may pose a health risk to the patient.

Information from the National Library of Medicine

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


Contacts
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Contact: Syneos Health

Locations
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United States, North Carolina
Syneos Health Recruiting
Raleigh, North Carolina, United States, 27604
Contact: Brittania O'Brien    919-926-6278    britania.obrien@syneoshealth.com   
Sponsors and Collaborators
MGB Biopharma Limited
Syneos Health

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Responsible Party: MGB Biopharma Limited
ClinicalTrials.gov Identifier: NCT03824795     History of Changes
Other Study ID Numbers: 1011464
2015-000489-73 ( EudraCT Number )
129507 ( Other Identifier: FDA IND Number )
MGB-BP-3-201 ( Other Identifier: Syneos Health Protocol Number )
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MGB Biopharma Limited:
Clostridium difficile
CDAD
MGB-BP-3
Novel anti-infective
Efficacy
Tolerability
Safety
Phase IIa

Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections