Clostridium Difficile InfectionPhase 2NCT03824795
Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD
A Phase 2 study testing MGB-BP-3 in people with Clostridium Difficile Infection, run by MGB Biopharma Limited at 9 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- MGB-BP-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 7 Feb 2019to 3 Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Age 18 years or older of any gender.
- Inpatients and/or outpatients who are able to attend all scheduled visits.
- Patients with the first episode or the first recurrence of mild or moderate CDAD.
- 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:
- Patients with severe complicated CDAD (including hypotension or shock, ileus, megacolon, pseudomembranous colitis).
- A white blood cell count higher than 15,000 cells/mL.
- A serum creatinine level greater than or equal to 1.5 times ULN.
- Elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater than ULN.
- Inflammatory bowel disease (ulcerative colitis or Crohn's disease), microscopic colitis, or irritable bowel syndrome with chronic diarrhea.
- Any other non-C difficile diarrhea.
- Received treatment with a fecal transplant within 7 days and/or is anticipated to receive a fecal transplant during the study.
- Major gastrointestinal surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).
- Received laxatives within the previous 48 hours.
- Pregnant or lactating women.
- Prior (within 180 days of Screening) or current use of anti-toxin antibodies.
- Have received a vaccine against C difficile.
- Any condition for which, in the opinion of the investigator, the treatment may pose a health risk to the patient.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Anne Arundel Medical Centre
Annapolis, Maryland, 21401
Mercury Street Medical Group PLLC
Butte, Montana, 59701
Verity Research Inc.
Fairfax, Virginia, 22031
Biopharma Informatic LLC
Houston, Texas, 77084
Snake River Research PLLC
Idaho Falls, Idaho, 83404
Florida International Medical Research
Miami, Florida, 33155
Ochsner Clinic Foundation Infectious Disease Research
New Orleans, Louisiana, 70121
Omega Research Maitland LLC
Orlando, Florida, 32810
About this study
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)
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).
Read the 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.
- Conditions
- Clostridium Difficile Infection
- Being tested
- MGB-BP-3
- Keywords
- Clostridium difficile, CDAD, MGB-BP-3, Novel anti-infective, Efficacy, Tolerability, Safety, Phase IIa
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGB-BP-3Drug
Also called No other names - not applicable
MGB-BP-3
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 125mg b.i.d. for 10 days | Active comparator | Patients will be administered an oral dose of 125mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10). Receives: Drug: MGB-BP-3 |
| Group 2: 250mg b.i.d. for 10 days | Active comparator | Patients will be administered an oral dose of 250mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10). Receives: Drug: MGB-BP-3 |
| Group 3: 500mg b.i.d. for 10 days | Active comparator | Patients will be administered an oral dose of 500mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10). Receives: Drug: MGB-BP-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0.
Incidence of treatment emergent adverse events (Safety and Tolerability of up to 3 incremental doses of MGB-BP-3 in patients with CDAD).
Measured: 40 days
Initial cure rate at 12 days post initiation of therapy.
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.
Measured: 12 days
Secondary outcomes (3)
CDAD Recurrence
Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.
Measured: Up to 8 weeks
Peak plasma concentration (Cmax).
Days 1, 5 and 10.
Measured: 10 days
Time to peak plasma concentration (Tmax).
Days 1, 5 and 10.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start7 Feb 2019
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- MGB Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Miroslav Ravic, MD, Study director, MGB Biopharma Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824795
- Sponsor's protocol ID
- 1011464
- Other IDs
- 2015-000489-73, 129507, MGB-BP-3-201, 2015
- Status last verified
- Apr 2020
- First submitted
- 24 Jan 2019
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03824795
- Acronym / sponsor ID
- 1011464
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile, CDAD, MGB-BP-3, Novel anti-infective, Efficacy, Tolerability, Safety, Phase IIa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- MGB Biopharma LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open-label study with 3 sequential groups of 10 patients with CDAD with a staggered start.
| Arm | Type | Receives |
|---|---|---|
| Group 1: 125mg b.i.d. for 10 days | Active comparator | Drug: MGB-BP-3Patients will be administered an oral dose of 125mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10). |
| Group 2: 250mg b.i.d. for 10 days | Active comparator | Drug: MGB-BP-3Patients will be administered an oral dose of 250mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10). |
| Group 3: 500mg b.i.d. for 10 days | Active comparator | Drug: MGB-BP-3Patients will be administered an oral dose of 500mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGB-BP-3Also: No other names - not applicableMGB-BP-3 | Drug | Group 1: 125mg b.i.d. for 10 days, Group 2: 250mg b.i.d. for 10 days, Group 3: 500mg b.i.d. for 10 days |
Primary outcome
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.
3 secondary outcomes
CDAD Recurrence
Time frame: Up to 8 weeks
Peak plasma concentration (Cmax).
Time frame: 10 days
Time to peak plasma concentration (Tmax).
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miroslav Ravic, MD study director
MGB Biopharma Ltd.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MGB-BP-3 in people with Clostridium Difficile Infection, run by MGB Biopharma Limited at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0. (time frame: 40 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.