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AzTrials

Inflammatory Bowel Disease (IBD)Phase 4PROFILENCT02437591

Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

A Phase 4 study testing fidaxomicin in people with Inflammatory Bowel Disease (IBD) and Clostridium Difficile Infection (CDI), run by Astellas Pharma Europe Ltd. at 12 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
fidaxomicin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
12 sitesin 7 countries
Study dates
13 Aug 2015to 24 Oct 2016
Phase
Phase 4
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

Who may be able to join

  • Confirmed diagnosis or history of IBD for at least 3 months
  • Subject has have active IBD defined by :
  • partial MAYO score (ulcerative colitis subjects) of 2 or more, where at least 1 point has to originate from blood in stool
  • Harvey-Bradshaw Index (HBI) (Crohn's disease subjects) of 5 or more, excluding points for complications
  • CDI confirmed positive according to local standard testing for the presence of C. difficile within 48 hr prior to enrollment
  • Female subject is not breastfeeding at Screening or while participating in this study
Show all 9Show fewer
  • Subject agrees to practice effective birth control from Screening and while participating in this study
  • Subject agrees not to participate in another interventional study while participating in this study
  • Male partner agrees not to donate sperm starting at screening and throughout the investigational period.

Who cannot join

  • Subject has received more than one day of dosing of any CDI therapy within the 48 hrs prior to enrollment
  • Subject is unable to swallow oral study medication
  • Presence of an ostomy or short bowel syndrome
  • Subject has a current diagnosis of toxic megacolon
  • Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol
  • Subject has been enrolled into this study previously, has taken any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor
Show all 9Show fewer
  • Subject has previously participated in a CDI vaccine study
  • Subject has hypersensitivity to FDX or any of its components
  • Subject has a condition which, in the Investigator's opinion, makes the Subject unsuitable for study participation

Trial locations and contacts

12 sites in 7 countries.

12 sites in 7 countries

Russia3 sites

  • Site RU70003

    Moscow, 119435

  • Site RU70002

    Moscow, 129110

  • Site RU70001

    Saint Petersburg, 196247

Other trials in Russia

France2 sites

  • Site FR33002

    Clichy, 92110

  • Site FR33001

    Paris, 75012

Other trials in France

Italy2 sites

  • Site IT39003

    Padova, 35128

  • Site IT39001

    Roma

Other trials in Italy

Poland2 sites

  • Site PL48002

    Warsaw, 02-507

  • Site PL48003

    Warsaw, 02-781

Other trials in Poland

Austria1 site

  • Site AT43001

    Graz, 8036

Other trials in Austria

Greece1 site

  • Site GR30004

    Athens, 11527

Other trials in Greece

United Kingdom1 site

  • Site GB44002

    London, E11 1NR

Other trials in United Kingdom

About this study

Official title: Open Label Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI).

This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.

Being tested
fidaxomicin
Keywords
ASP2819, PAR-101, OPT-80, Inflammatory Bowel Disease (IBD), Clostridium difficile Infection (CDI), fidaxomicin, Dificlir
Medical subject headings
Inflammatory Bowel Diseases, Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fidaxomicinDrug

    Also called PAR-101, OPT-80, Dificlir, ASP2819

    oral

Study groups in NCT02437591
Study groupRoleWhat they receive
fidaxomicinExperimentaltablet twice daily
Receives: Drug: fidaxomicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic parameter of fidaxomicin: Maximum plasma concentration (Cmax)

    Measured: Day 1, Day 5 and Day 10

  2. Pharmacokinetic parameter of OP-1118: Maximum plasma concentration (Cmax)

    Measured: Day 1, Day 5 and Day 10

  3. Pharmacokinetic parameter of fidaxomicin: Area under the curve from 0 to 12 hrs (AUC12)

    Measured: Day 1

  4. Pharmacokinetic parameter of OP-1118: Area under the curve from 0 to 12 hrs (AUC12)

    Measured: Day 1

  5. Pharmacokinetic parameter of fidaxomicin and OP-1118: Metabolite to Parent Ratio (MPR)

    Measured: Day 1

  6. Pharmacokinetic parameter of fidaxomicin: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau)

    Measured: Day 5 and Day 10

  7. Pharmacokinetic parameter of OP-1118: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau)

    Measured: Day 5 and Day 10

  8. Pharmacokinetic parameter of fidaxomicin: The time after dosing when Cmax occurs (tmax)

    Measured: Day 1, Day 5 and Day 10

  9. Pharmacokinetic parameter of OP-1118: The time after dosing when Cmax occurs (tmax)

    Measured: Day 1, Day 5 and Day 10

  10. Pharmacokinetic parameter of fidaxomicin: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)

    Measured: Day 5 and Day 10

  11. Pharmacokinetic parameter of OP-1118: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)

    Measured: Day 5 and Day 10

  12. Pharmacokinetic parameter of fidaxomicin: Concentration immediately prior to dosing at multiple dosing (Ctrough)

    Measured: Day 5 and Day 10

  13. Pharmacokinetic parameter of OP-1118: Concentration immediately prior to dosing at multiple dosing (Ctrough)

    Measured: Day 5 and Day 10

Secondary outcomes (6)

  1. CDI clinical response

    Measured: Day 12

  2. Microbiological response of C. difficile total viable count, spore count, microbiological eradication and negative CDI toxin assay

    Measured: Day 5 and Day 10

  3. Stool concentrations of fidaxomicin and its metabolite OP-1118

    Measured: Day 1, Day 5 and Day 10

  4. Length of hospital stay, readmissions and resource utilization

    Measured: up to Day 180

  5. Safety as assessed by incidence and severity of adverse events

    Measured: up to Day 180

  6. Health related quality of life as assessed by short IBDQ score

    Inflammatory Bowel Disease Questionnaire (IBDQ)

    Measured: Day 10, Day 26, Day 40, Day 90 and Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2015 (estimated)
  2. Study start13 Aug 2015
  3. Primary completion12 May 2016
  4. Study completion24 Oct 2016

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02437591
Sponsor's protocol ID
2819-MA-1003
Other IDs
2014-003002-32, 2014
Acronym
PROFILE
Status last verified
Oct 2024
First submitted
5 May 2015
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Hogenauer C, Mahida Y, Stallmach A, Marteau P, Rydzewska G, Ivashkin V, Gargalianos-Kakolyris P, Michon I, Adomakoh N, Georgopali A, Tretter R, Karas A, Reinisch W. Pharmacokinetics and safety of fidaxomicin in patients with inflammatory bowel disease and Clostridium difficile infection: an open-label Phase IIIb/IV study (PROFILE). J Antimicrob Chemother. 2018 Dec 1;73(12):3430-3441. doi: 10.1093/jac/dky368.

    PubMed 30260412

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fidaxomicin in people with Inflammatory Bowel Disease (IBD) and Clostridium Difficile Infection (CDI), run by Astellas Pharma Europe Ltd. at 12 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Russia, France, Italy, Poland, Austria and 2 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Pharmacokinetic parameter of fidaxomicin: Maximum plasma concentration (Cmax) (time frame: Day 1, Day 5 and Day 10). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02437591, which also lists 1 linked publication.

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 31 Oct 2024.

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