Trial · NCT04411082
A Study of IMR-687 in Subjects With Beta Thalassemia
NCT04411082, Phase 2, Terminated, Cardurion Pharmaceuticals, Inc.; results first posted 2022-06-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of IMR-687 in Subjects With Beta Thalassemia. Trials, record NCT04411082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04411082
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of IMR-687 in Subjects With Beta Thalassemia
- NCT number
- NCT04411082
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 122 participants, actual
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.
- Conditions
- β Thalassemia
- Interventions
- IMR-687, Placebo
- First posted
- 2020-06-02
- Last updated
- 2025-05-15
- Other registries' IDs
- eudract:2019-002989-12
- Results first posted
- 2022-06-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | IMR-687 Safety and Tolerability | Baseline to Week 40 | Incidence and severity of Adverse Events Incidence and severity of Serious Adverse Events |
| Secondary | TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 12 to Week 24 | Baseline to Week 24 | Proportion of patients with ≥33% hematological improvement (as measured by reduced transfusion burden) from Week 12 to Week 24 compared to the 12 weeks prior to Baseline (Day 1) |
| Secondary | NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 12 to Week 24 in the Absence of Transfusions. | Baseline to Week 24 | Proportion of subjects with an increase from baseline of ≥1.0 g/dL in mean Hb values at Week 12 to Week 24 in the absence of transfusions. |
| Secondary | NTDT Patients: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 12 to Week 24 in Absence of Transfusions | Baseline to Week 24 | Proportion of subjects with an increase from baseline of ≥3% in mean HbF values at Week 12 to Week 24 in absence of transfusions |
| Secondary | TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 24 to Week 36 | Baseline to Week 36 | Proportion of patients with ≥33% hematological improvement from Week 24 to Week 36 compared to the 12 weeks prior to Baseline (Day 1) |
| Secondary | TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50 % Hematological Improvement From Week 12 to Week 24 | Baseline to Week 24 | Proportion of patients with ≥50% hematological improvement from Week 12 to Week 24 compared to the 12 weeks prior to Baseline (Day 1) |
| Secondary | TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50% Hematological Improvement From Week 24 to Week 36 | Baseline to Week 36 | Proportion of patients with ≥50% hematological improvement from Week 24 to Week 36 compared to the 12 weeks prior to Baseline (Day 1) |
| Secondary | NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 24 to Week 36 in the Absence of Transfusions | Baseline to Week 36 | Proportion of subjects with an increase from baseline of ≥1.0 g/dL in mean Hb values at Week 24 to Week 36 in the absence of transfusions. |
| Secondary | NTDT: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 24 to Week 36 in Absence of Transfusions | Baseline to Week 36 | Proportion of subjects with an increase from baseline of ≥3% in mean HbF values at Week 24 to Week 36 in absence of transfusions |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | IMR-687 Safety and Tolerability | Baseline to Week 40 | Safety Analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 12 to Week 24 | Baseline to Week 24 | Per Protocol Analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 12 to Week 24 in the Absence of Transfusions. | Baseline to Week 24 | Per protocol analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | NTDT Patients: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 12 to Week 24 in Absence of Transfusions | Baseline to Week 24 | Per Protocol Analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 24 to Week 36 | Baseline to Week 36 | Per Protocol Analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50 % Hematological Improvement From Week 12 to Week 24 | Baseline to Week 24 | Per Protocol Analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50% Hematological Improvement From Week 24 to Week 36 | Baseline to Week 36 | Per Protocol Analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 24 to Week 36 in the Absence of Transfusions | Baseline to Week 36 | Per Protocol Analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | NTDT: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 24 to Week 36 in Absence of Transfusions | Baseline to Week 36 | Per Protocol Analysis | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| IMR-687 Safety and Tolerability | TDT High Dose | Treatment emergent Adverse Events | 25 | Participants | |
| IMR-687 Safety and Tolerability | TDT Low Dose | Treatment emergent Adverse Events | 22 | Participants | |
| IMR-687 Safety and Tolerability | TDT Placebo | Treatment emergent Adverse Events | 15 | Participants | |
| IMR-687 Safety and Tolerability | NTDT High Dose | Treatment emergent Adverse Events | 18 | Participants | |
| IMR-687 Safety and Tolerability | NTDT Low Dose | Treatment emergent Adverse Events | 12 | Participants | |
| IMR-687 Safety and Tolerability | NTDT Placebo | Treatment emergent Adverse Events | 6 | Participants | |
| IMR-687 Safety and Tolerability | TDT High Dose | Treatment emergent Adverse Event related to study drug | 19 | Participants | |
| IMR-687 Safety and Tolerability | TDT Low Dose | Treatment emergent Adverse Event related to study drug | 15 | Participants | |
| IMR-687 Safety and Tolerability | TDT Placebo | Treatment emergent Adverse Event related to study drug | 8 | Participants | |
| IMR-687 Safety and Tolerability | NTDT High Dose | Treatment emergent Adverse Event related to study drug | 11 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TDT High Dose | 29 | |
| Overall Study | STARTED | TDT Low Dose | 25 | |
| Overall Study | STARTED | TDT Placebo | 20 | |
| Overall Study | STARTED | NTDT High Dose | 24 | |
| Overall Study | STARTED | NTDT Low Dose | 12 | |
| Overall Study | STARTED | NTDT Placebo | 12 | |
| Overall Study | COMPLETED | TDT High Dose | 18 | |
| Overall Study | COMPLETED | TDT Low Dose | 16 | |
| Overall Study | COMPLETED | TDT Placebo | 16 | |
| Overall Study | COMPLETED | NTDT High Dose | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events138
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 | Headache | Nervous system disorders | TDT High Dose | 10 | 29 | |
| other | Headache | Nervous system disorders | TDT Low Dose | 10 | 25 | |
| other | Headache | Nervous system disorders | TDT Placebo | 7 | 20 | |
| other | Headache | Nervous system disorders | NTDT High Dose | 5 | 24 | |
| other | Headache | Nervous system disorders | NTDT Low Dose | 2 | 12 | |
| other | Headache | Nervous system disorders | NTDT Placebo | 2 | 12 | |
| other | Nausea | Gastrointestinal disorders | TDT High Dose | 11 | 29 | |
| other | Nausea | Gastrointestinal disorders | TDT Low Dose | 6 | 25 | |
| other | Nausea | Gastrointestinal disorders | TDT Placebo | 1 | 20 | |
| other | Nausea | Gastrointestinal disorders | NTDT High Dose | 5 | 24 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TDT High Dose | 0 | 29 |
| Total, all-cause mortality | TDT Low Dose | 0 | 25 |
| Total, all-cause mortality | TDT Placebo | 0 | 20 |
| Total, all-cause mortality | NTDT High Dose | 0 | 24 |
| Total, all-cause mortality | NTDT Low Dose | 0 | 12 |
| Total, all-cause mortality | NTDT Placebo | 0 | 12 |
| Total, other adverse events | TDT High Dose | 25 | 29 |
| Total, other adverse events | TDT Low Dose | 22 | 25 |
| Total, other adverse events | TDT Placebo | 15 | 20 |
| Total, other adverse events | NTDT High Dose | 18 | 24 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36637054 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04411082
GET https://conductscience.org/api/trials/v1/NCT04411082/results?page=2