Ovarian CancerPhase 4SOLINCT04330040

Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer

A Phase 4 study testing Olaparib in people with Ovarian Cancer and Breast Cancer, run by AstraZeneca at 16 sites in India.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 99 years, women only
Conditions the study is for: Ovarian Cancer, Breast Cancer
What is being tested?: Olaparib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 202 participants
Where: 16 sitesIndia
Study dates: 25 May 2020to 30 Sep 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 99 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures..
Female Subjects with ≥ 18 years of age
Subjects receiving olaparib for the following indications in ovarian cancer:
for the maintenance treatment of adult subjects with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Subjects receiving olaparib for the following indication in breast cancer:
in subjects with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Subjects with HR-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment

Who cannot join

Patients with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
pregnant and/or lactating women.
Patients with a previously or currently diagnosed MDS/ AML or pneumonitis.
Patients who have not recovered sufficiently from prior surgery or anticancer treatment.
Patients who have known history of hepatitis B or hepatitis C
Patients with active infection such as TB.
Participation in another clinical study with a study drug administered in the last 3 months

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

India16 sites

Research Site
Ahmedabad, 380009
Research Site
Bhubaneswar, 751007
Research Site
Chandigarh, 160012
Research Site
Delhi, 110029
Research Site
Faridabad, 121001
Research Site
Guwahati, 781023
Research Site
Kochi, 682041
Research Site
Kolkata, 700099
Research Site
Kolkata, 700160
Research Site
Madurai, 625107
Research Site
Mumbai, 400012
Research Site
Mumbai, 400053
Research Site
New Delhi, 110 085
Research Site
New Delhi, 110005
Research Site
New Delhi, 110063
Research Site
Vellore, 632004

Other trials in India

About this study

Official title: A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients With Platinum Sensitive Relapsed Ovarian Cancer Who Are in Complete or Partial Response Following Platinum Based Chemotherapy and Metastatic Breast Cancer With Germline BRCA1/2 Mutation

Read the detailed description

A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA(BReast CAncer gene)1/2 Mutation As per recommendation from DCGI(Drug Controller general of of India), the current phase-IV study is planned with the aim to assess the safety in Indian subjects receiving olaparib as per the approved label indications in India in accordance with the requirements of the Health Authorities of India. This study attempts to descriptively elucidate the safety of Olaparib in Indian subjects receiving olaparib as per the Indian regulatory approved indications in India. The data obtained from the present study will help to understand the safety profile of olaparib in Indian patients.

Conditions: Ovarian Cancer, Breast Cancer
Being tested: Olaparib
Keywords: Ovarian Cancer; Breast Cancer, Olaparib
Medical subject headings: Ovarian Neoplasms, Breast Neoplasms

What participants receive

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

OlaparibDrug
Tablet

Study groups in NCT04330040
Study group	Role	What they receive
Single Arm	Experimental	Intervention: Drug: Olaparib Receives: Drug: Olaparib

What is being measured

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

Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Comparison between the cohorts was not the objective for the study. The hematology data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population .
EOT = end of treatment
Measured: Baseline to EOT (approximately 6 months)
Haematology: Haemoglobin Parameters
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. The haemoglobin parameter data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population .
EOT = end of treatment
Measured: Baseline to EOT (approximately 6 months)
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
The number of participants who experienced hematology results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented.
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
EOT = end of treatment
Measured: Baseline to EOT (approximately 6 months)
Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT
The number of participants who experienced hemoglobin results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented..
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
EOT = end of treatment
Measured: Baseline to EOT (approximately 6 months)
Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Remarkable changes were assessed by the investigator.
EOT = end of treatment
Measured: Baseline to EOT (approximately 6 months)
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal clinically significant results at Baseline and EOT are presented.
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Measured: Baseline to EOT (approximately 6 months)
Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Remarkable changes were assessed by the investigator.
EOT = end of treatment
Measured: Baseline to EOT (approximately 6 months)
WHO Performance Status
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Measured: Baseline and End of study visit (200 days)

Timeline

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

25 May 202030 Sep 2022

First posted1 Apr 2020
Study start25 May 2020
Primary completion30 Sep 2022
Study completion30 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ovarian CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Model description: A Prospective, Multicentre, Phase-IV Clinical Trial
Masking: None (open label)
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04330040
Sponsor's protocol ID: D0816R00025
Acronym: SOLI
Status last verified: Feb 2025
First submitted: 30 Mar 2020
Last updated: 10 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Recruiting
Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
High Grade Serous Ovarian Cancer
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma

All Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients With Platinum Sensitive Relapsed Ovarian Cancer Who Are in Complete or Partial Response Following Platinum Based Chemotherapy and Metastatic Breast Cancer With Germline BRCA1/2 Mutation
ClinicalTrials.gov ID: NCT04330040
Acronym / sponsor ID: SOLI / D0816R00025
Conditions: Ovarian Cancer, Breast Cancer
Keywords: Ovarian Cancer; Breast Cancer, Olaparib
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 25 May 2020 (actual)
Primary completion: 30 Sep 2022 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 1 Apr 2020 (actual)
Results: Posted 10 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A Prospective, Multicentre, Phase-IV Clinical Trial

Arm	Type	Receives
Single Arm	Experimental	Drug: OlaparibIntervention: Drug: Olaparib

Who may qualify

Ages: 18 to 99 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures..
Female Subjects with ≥ 18 years of age
Subjects receiving olaparib for the following indications in ovarian cancer:
for the maintenance treatment of adult subjects with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Subjects receiving olaparib for the following indication in breast cancer:

Key exclusion criteria (7 listed)

Patients with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
pregnant and/or lactating women.
Patients with a previously or currently diagnosed MDS/ AML or pneumonitis.
Patients who have not recovered sufficiently from prior surgery or anticancer treatment.
Patients who have known history of hepatitis B or hepatitis C

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OlaparibTablet	Drug	Single Arm

Primary outcome

Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Time frame: Baseline to EOT (approximately 6 months)
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Comparison between the cohorts was not the objective for the study. The hematology data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment
Haematology: Haemoglobin Parameters
Time frame: Baseline to EOT (approximately 6 months)
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. The haemoglobin parameter data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
Time frame: Baseline to EOT (approximately 6 months)
The number of participants who experienced hematology results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment
Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT
Time frame: Baseline to EOT (approximately 6 months)
The number of participants who experienced hemoglobin results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented.. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment
Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator
Time frame: Baseline to EOT (approximately 6 months)
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Time frame: Baseline to EOT (approximately 6 months)
Abnormal clinically significant results at Baseline and EOT are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator
Time frame: Baseline to EOT (approximately 6 months)
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment
WHO Performance Status
Time frame: Baseline and End of study visit (200 days)
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.

Results and safety

Results posted to the registry on 10 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ovarian Cancer	163	104
Breast Cancer	38	18
Both Ovarian Cancer and Breast Cancer	1	1

Primary outcome: Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters

Time frame: Baseline to EOT (approximately 6 months). Count of participants. Unit: Participants

Measure	Ovarian n = 161	Breast Cancer n = 38	Both Ovarian and Breast Cancer n = 1	Cancer Type: Overall n = 200
Basophils Absolute Count: EOT Above Normal	0	0	0	0
Basophils Absolute Count: EOT Normal	72	12	1	85
Basophils Absolute Count: EOT Below Normal	41	10	0	51
Basophils Absolute Count: EOT Missing	48	16	0	64
Eosinophils Absolute Count: EOT Above Normal	2	0	0	2
Eosinophils Absolute Count: EOT Normal	90	20	1	111
Eosinophils Absolute Count: EOT Below Normal	21	3	0	24
Eosinophils Absolute Count: EOT Missing	48	15	0	63

Population analysed: The safety analysis set included all participants who received the study drug (200 overall).

Primary outcome: Haematology: Haemoglobin Parameters

Time frame: Baseline to EOT (approximately 6 months). Count of participants. Unit: Participants

Measure	Ovarian Cancer n = 161	Breast Cancer n = 38	Both Ovarian and Breast Cancer n = 1	Cancer Type: Overall n = 200
EOT Above Normal	0	0	0	0
EOT Normal	15	5	0	20
EOT Below Normal	115	21	1	137
EOT Missing	31	12	0	43

Population analysed: The safety analysis set included all participants who received the study drug (200 overall).

Primary outcome: Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT

Time frame: Baseline to EOT (approximately 6 months). Count of participants. Unit: Participants

Measure	Ovarian Cancer n = 161	Breast Cancer n = 38	Both Ovarian and Breast Cancer n = 1	Cancer Type: Overall n = 200
Basophils Absolute Count	13	5	0	18
Eosinophils Absolute Count	8	2	0	10
Leucocytes WBC	17	6	0	23
Lymphocytes Absolute Count	20	8	1	29
Monocytes Absolute Count	21	6	0	27
Neutrophils Absolute Count	9	5	0	14
Platelets	23	4	0	27

Population analysed: The safety analysis set included all participants who received the study drug (200 overall).

Primary outcome: Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT

Time frame: Baseline to EOT (approximately 6 months). Count of participants. Unit: Participants

Measure	Ovarian Cancer n = 161	Breast Cancer n = 38	Both Ovarian and Breast Cancer n = 1	Cancer Type: Overall n = 200
Value	17	11	0	28

Population analysed: The safety analysis set included all participants who received the study drug (200 overall).

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ovarian Cancer	24 of 161 (14.9%)	148 of 161 (91.9%)	3 of 161
Breast Cancer	7 of 38 (18.4%)	30 of 38 (78.9%)	3 of 38
Both Ovarian Cancer and Breast Cancer	1 of 1 (100%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Redacted CSPLink provided by the sponsor.
Redacted SAPLink provided by the sponsor.
Redacted CSR SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Olaparib in people with Ovarian Cancer and Breast Cancer, run by AstraZeneca at 16 sites in India.

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 6 inclusion and 7 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in India. 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?

Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters (time frame: Baseline to EOT (approximately 6 months)). The study lists 8 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 NCT04330040.

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 10 Mar 2025.