Clinical Trial Results:
An open-label, multicentre, single arm study to assess the efficacy and safety of triptorelin 6-month formulation administered subcutaneously in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a GnRH analogue
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Summary
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EudraCT number |
2021-005719-29 |
Trial protocol |
FR BE ES LT NL CZ |
Global end of trial date |
08 Jul 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Jul 2025
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First version publication date |
20 Jul 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
D-FR-52014-245
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05458856 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Ipsen Pharma SAS
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Sponsor organisation address |
70 rue Balard, PARIS, France, 75015
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Public contact |
Medical Director, Ipsen Pharma SAS, clinical.trials@ipsen.com
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Scientific contact |
Medical Director, Ipsen Pharma SAS, clinical.trials@ipsen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Jul 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Jul 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the efficacy of triptorelin embonate 22.5 milligrams (mg) 6-month formulation administered subcutaneously (SC) in maintaining serum testosterone castrate levels in participants with advanced prostate cancer previously treated and castrated with a gonadotropin-releasing hormone (GnRH) analogue.
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Protection of trial subjects |
The study was conducted under the provisions of the Declaration of Helsinki, in accordance with the International Conference on Harmonisation Consolidated Guideline on Good Clinical Practice and in compliance with independent ethics committees and informed consent regulations.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Aug 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Czechia: 8
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Country: Number of subjects enrolled |
France: 31
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Country: Number of subjects enrolled |
Germany: 7
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Country: Number of subjects enrolled |
Lithuania: 51
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Country: Number of subjects enrolled |
Netherlands: 20
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Country: Number of subjects enrolled |
Spain: 30
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Worldwide total number of subjects |
147
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EEA total number of subjects |
147
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
24
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From 65 to 84 years |
116
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85 years and over |
7
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Recruitment
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Recruitment details |
This Phase III, multicenter, open-label, single arm study was conducted at 26 investigational sites in 6 countries from 30-Aug-2022 to 08-Jul-2024 in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a GnRH analogue. | ||||||||||||||||||
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Pre-assignment
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Screening details |
The study consisted of a screening period (Day -28 to Day -1), study treatment administration on Days 1 and 169 (with visits on Days 3, 7, 29, 85, 141, 171, 175, 253, 309) and an end of study/early discontinuation visit on Day 337. A total of 147 participants were enrolled in the study. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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Triptorelin Embonate 22.5 mg | ||||||||||||||||||
Arm description |
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Triptorelin embonate
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Investigational medicinal product code |
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Other name |
Decapeptyl®, Pamorelin®, Diphereline®
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Pharmaceutical forms |
Powder and solvent for suspension for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Triptorelin embonate 22.5 mg was administered as an SC injection on Days 1 and 169.
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Baseline characteristics reporting groups
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Reporting group title |
Triptorelin Embonate 22.5 mg
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Reporting group description |
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Triptorelin Embonate 22.5 mg
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Reporting group description |
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169. | ||
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End point title |
Percentage of Participants who Maintained Castrate Levels of Serum Testosterone During the Study [1] | ||||||||
End point description |
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Maintenance of castration during the study was defined as testosterone <1.735 nanomoles per liter (nmol/L) (<50 nanograms/deciliter [ng/dL]) at Days 29, 85, 141, 169, 253, 309 and 337. The full analysis set (FAS) included all participants who signed an informed consent form (ICF) and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337).
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End point type |
Primary
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End point timeframe |
Up to Day 337
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As the endpoint is descriptive in nature, no statistical analysis is provided. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337 | ||||||||||||||||||||||
End point description |
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone <1.735 nmol/L (<50 ng/dL). The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337).
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End point type |
Secondary
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End point timeframe |
Days 29, 85, 141, 169, 253, 309 and 337
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Percentage of Participants With a Serum Testosterone Level <0.694 nmol/L (<20 ng/dL) During the Study | ||||||||
End point description |
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337).
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End point type |
Secondary
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End point timeframe |
Up to Day 337
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants With a Serum Testosterone Level <0.694 nmol/L (<20 ng/dL) on Days 29, 85, 141, 169, 253, 309 and 337 | ||||||||||||||||||||||
End point description |
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337).
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End point type |
Secondary
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End point timeframe |
Days 29, 85, 141, 169, 253, 309 and 337
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169 | ||||||||||||||||
End point description |
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone <1.735 nmol/L (<50 ng/dL). Percentages are rounded off to the tenth decimal place. The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337).
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End point type |
Secondary
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End point timeframe |
On Days 3, 7, 171, and 175
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337 | ||||||||||||
End point description |
Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of the difference between the PSA values at Days 169 and 337 and the baseline value divided by the baseline value. The baseline value was the last sample prior to the first injection. The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337). Only those participants with data collected at specified timepoints are reported. Here, n=number of participants with data collected for each specified category.
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End point type |
Secondary
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End point timeframe |
Baseline (prior to injection on Day 1), Days 169 and 337
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance | ||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. TEAEs were AEs that started or worsened on or after the first study treatment administration and within 168 days after the last dose of study treatment, or up to Day 337, whichever was later. Local tolerance was assessed 2 hours after each injection by examination of injection site for signs such as but not limited to tenderness, redness, bruising, erythema, swelling, rash, pain, itching, induration, hematoma, ulceration or necrosis. The safety set included all participants who received at least 1 dose of study treatment.
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End point type |
Secondary
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End point timeframe |
From first dose of study treatment (Day 1) up to end of study visit (Day 337)
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| No statistical analyses for this end point | |||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Serious AEs, non-serious AEs and deaths were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days
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Adverse event reporting additional description |
The safety set included all participants who received at least 1 dose of study treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
27.0
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Reporting groups
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Reporting group title |
Triptorelin Embonate 22.5 mg
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Reporting group description |
Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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13 Sep 2022 |
Objectives and endpoints were modified to add clarification on the primary and secondary estimands for the primary endpoint. Number of participants was revised from 153 to 145, to account for decrease in dropout rate from 15% to 10%. An exclusion criteria related to the use of other therapy for prostate cancer during the study was modified to avoid exclusion of eligible participants. The list of prohibited medications during the study was modified to include abiraterone. Clarification on withdrawal of participants with lack of efficacy during the study was added to the protocol. Blood volume collection during the study was increased from 65 milliliter (mL) to 153 mL, to accommodate blood samples needed for central laboratory testing. Primary objective was modified to include definition of “maintenance of castration". Definition of FAS was modified to include the participants who received 2 administrations of study intervention and completed all visits for testosterone measurement. Administrative changes resulting due to changes in sponsor signatory and medical monitor were made. Minor inconsistencies and typographical mistakes were corrected. |
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04 Dec 2023 |
Reporting of Coronavirus disease 2019 (COVID-19) cases was modified. This meant that COVID-19 was no longer to be reported as an SAE unless the occurrence of COVID-19 met the defined seriousness criteria. Reason for temporary discontinuation of study treatment was updated to comply with protocol template guidance. Definition of a lost to follow-up participant was updated to comply with protocol template guidance. Administrative changes resulting due to changes in sponsor signatory and medical monitor were made. Minor inconsistencies and typographical mistakes were corrected. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
