Trial · NCT03746483
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
NCT03746483, Phase 2, Completed, Entero Therapeutics; results first posted 2022-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis. Trials, record NCT03746483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03746483
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
- NCT number
- NCT03746483
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Entero Therapeutics
- Conditions
- Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
- Interventions
- MS1819, Porcine PERT
- First posted
- 2018-11-19
- Last updated
- 2022-06-06
- Results first posted
- 2022-06-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of MS1819-SD: Coefficient of Fat Absorption (CFA) | 3 weeks | The Coefficient of Fat Absorption (CFA%) is defined as: \[72-hour fat intake (g) - 72-hour fat excretion (g)/72-hour fat intake(g)\] x 100 = CFA% The threshold for CFA results (\>80%) is considered clinically significant for treatment effectiveness by the FDA. |
| Primary | Safety of MS1819-SD by Number of Participants Reporting 1 or More Adverse Events (AE) | 6 weeks | Number of participants reporting 1 or more adverse events |
| Primary | Safety of MS1819-SD by Number of Treatment Emergent Adverse Events (TEAEs) | 6 weeks | Number of Treatment emergent adverse events |
| Secondary | Stool Weights | 6 weeks | The relative efficacy of MS1819-SD compared to porcine PERT will be assessed using stool weights |
| Secondary | Signs and Symptoms of Malabsorption | 3 weeks | The relative efficacy of MS1819 compared to porcine PERT will be assessed using signs and symptoms of malabsorption. Abdominal pain, bloating, flatulence, increased stool quantity, and worsening of overall bowel habit were graded as 0 = none, 1 = mild, 2 = moderate, or 3 = severe. |
| Secondary | Coefficient of Nitrogen Absorption (CNA) | 3 weeks per group. | CNA at the end of each treatment period was expressed as the percentage of nitrogen (protein) absorbed from the subjects diet. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of MS1819-SD: Coefficient of Fat Absorption (CFA) | 3 weeks | modified Intent To Treat (mITT) | % CFA | MEAN |
| PRIMARY | Safety of MS1819-SD by Number of Participants Reporting 1 or More Adverse Events (AE) | 6 weeks | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety of MS1819-SD by Number of Treatment Emergent Adverse Events (TEAEs) | 6 weeks | Safety Population | Number of TEAEs reported | NUMBER |
| SECONDARY | Stool Weights | 6 weeks | mITT. Samples from 4 patients were not available for analysis due to discontinuation from the study. Three patients discontinued in the MS1819 group while 1 patient discontinued in the PERT group. | grams | MEAN |
| SECONDARY | Signs and Symptoms of Malabsorption | 3 weeks | Data presented at 3 weeks post first dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Coefficient of Nitrogen Absorption (CNA) | 3 weeks per group. | mITT. Samples from 4 patients were not available for analysis due to discontinuation from the study. Three patients discontinued in the MS1819 group while 1 patient discontinued in the PERT group. | % CNA | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of MS1819-SD: Coefficient of Fat Absorption (CFA) | MS1819 | 55.6 | Standard Deviation 21.44 | % CFA | |
| Efficacy of MS1819-SD: Coefficient of Fat Absorption (CFA) | PERT | 86.2 | Standard Deviation 7.39 | % CFA | |
| Safety of MS1819-SD by Number of Participants Reporting 1 or More Adverse Events (AE) | MS1819 | Number of subjects with any TEAEs | 13 | Participants | |
| Safety of MS1819-SD by Number of Participants Reporting 1 or More Adverse Events (AE) | PERT | Number of subjects with any TEAEs | 6 | Participants | |
| Safety of MS1819-SD by Number of Participants Reporting 1 or More Adverse Events (AE) | MS1819 | Number of subjects with TEAEs related to | 2 | Participants | |
| Safety of MS1819-SD by Number of Participants Reporting 1 or More Adverse Events (AE) | PERT | Number of subjects with TEAEs related to | 0 | Participants | |
| Safety of MS1819-SD by Number of Treatment Emergent Adverse Events (TEAEs) | MS1819 | Number of Treatment-emergent adverse event (TEAEs) | 19 | Number of TEAEs reported | |
| Safety of MS1819-SD by Number of Treatment Emergent Adverse Events (TEAEs) | PERT | Number of Treatment-emergent adverse event (TEAEs) | 8 | Number of TEAEs reported | |
| Safety of MS1819-SD by Number of Treatment Emergent Adverse Events (TEAEs) | MS1819 | Number of serious TEAEs reported | 0 | Number of TEAEs reported | |
| Safety of MS1819-SD by Number of Treatment Emergent Adverse Events (TEAEs) | PERT | Number of serious TEAEs reported | 0 | Number of TEAEs reported |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MS1819 2240 mg/Day (3 Weeks) Then PERT Pre-study Dose (3 Weeks) | 21 | |
| Overall Study | STARTED | PERT Pre-study Dose (3 Weeks) Then MS1819 2240 mg/Day (3 Weeks) | 20 | |
| Overall Study | COMPLETED | MS1819 2240 mg/Day (3 Weeks) Then PERT Pre-study Dose (3 Weeks) | 15 | |
| Overall Study | COMPLETED | PERT Pre-study Dose (3 Weeks) Then MS1819 2240 mg/Day (3 Weeks) | 17 | |
| Overall Study | NOT COMPLETED | MS1819 2240 mg/Day (3 Weeks) Then PERT Pre-study Dose (3 Weeks) | 6 | |
| Overall Study | NOT COMPLETED | PERT Pre-study Dose (3 Weeks) Then MS1819 2240 mg/Day (3 Weeks) | 3 |
Source ClinicalTrials.gov
Adverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MS1819 | 2 | 40 | 2 |
| other | Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | PERT | 1 | 38 | 1 |
| other | Herpes Zoster | Infections and infestations | MS1819 | 1 | 40 | 1 |
| other | Herpes Zoster | Infections and infestations | PERT | 0 | 38 | 0 |
| other | Sinusitis | Infections and infestations | MS1819 | 1 | 40 | 1 |
| other | Sinusitis | Infections and infestations | PERT | 1 | 38 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | MS1819 | 1 | 40 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | PERT | 0 | 38 | 0 |
| other | Vulvovaginal mycotic infection | Infections and infestations | MS1819 | 1 | 40 | 1 |
| other | Vulvovaginal mycotic infection | Infections and infestations | PERT | 1 | 38 | 1 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MS1819 | 0 | 40 |
| Total, all-cause mortality | PERT | 0 | 38 |
| Total, other adverse events | MS1819 | 13 | 40 |
| Total, other adverse events | PERT | 6 | 38 |
| Total, serious adverse events | MS1819 | 0 | 40 |
| Total, serious adverse events | PERT | 0 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MS1819 vs PERT: deaths from any cause | Trial comparisons |
| MS1819 vs PERT: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03746483
GET https://conductscience.org/api/trials/v1/NCT03746483/results?page=2