Trial · NCT06514807
A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients
NCT06514807, Phase 3, Active not recruiting, AOP Orphan Pharmaceuticals AG
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients. Trials, record NCT06514807. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06514807
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients
- NCT number
- NCT06514807
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 117 participants, estimated
- Lead sponsor
- AOP Orphan Pharmaceuticals AG
- Conditions
- Essential Thrombocythaemia
- Interventions
- Ropeginterferon alfa-2b (BESREMi®)
- First posted
- 2024-07-23
- Last updated
- 2024-12-19
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Durable (for at least 3 months) peripheral blood count remission | At month 12 | PLTs ≤400 x 109/L AND WBC \<10 x 109/L |
| Primary | Absence of haemorrhagic or thrombotic events and absence of disease progression* | At month 12 | \*Progression is defined as conversion from asymptomatic to symptomatic splenomegaly or clinically relevant progression of spleen size at the Investigator's discretion, respectively. |
| Primary | Absence or Non-progression* in disease-related signs | At month 12 | \*Progression is defined as conversion from asymptomatic to symptomatic splenomegaly or clinically relevant progression of spleen size at the Investigator's discretion, respectively. |
| Primary | Durable (for at least 3 months) large symptoms improvement or maintenance of non-progression based on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)# | At month 12 | \# Large symptoms improvement for ET patients is defined as follows: * Baseline TSS ≥20: 10-points reduction in TSS * Baseline TSS 15-19, inclusive: 5-points reduction in TSS * Baseline TSS 10-14, inclusive: TSS decreases to ≤10 * Baseline TSS \<10: TSS stays \<10 |
| Secondary | Response at month 9, 18, 24, 30 and 36 | Month 9, 18, 24, 30 and 36 | |
| Secondary | Longitudinal changes in the ELN response rates over 12 months | up to 36 months | |
| Secondary | Time to first response (as defined by ELN criteria) | up to 36 months | |
| Secondary | Duration of first response (as defined by ELN criteria) | up to 36 months | |
| Secondary | Duration of first durable response (as defined by ELN criteria) | up to 36 months | |
| Secondary | Time to first peripheral blood count remission response | up to 36 months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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/NCT06514807
GET https://conductscience.org/api/trials/v1/NCT06514807/registered