Rare DiseasesPhase 2/3GNETNCT04651439
Severe Bullous Drug Eruption and Filgrastim
A Phase 2/3 study testing Filgrastim in people with Rare Diseases and Toxic Epidermal Necrolyses, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Toxic epidermal necrolysis (TEN) including Stevens Johnson (SJS) and Lyell syndromes represent the most severe drug eruptions. It is an allergic disorder caused by cytotoxic T lymphocytes, specific of drugs, responsible for the destruction of keratinocytes by apoptosis. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Rare Diseases, Toxic Epidermal Necrolyses
- What is being tested?
- Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesFrance
- Study dates
- 13 May 2022to 13 May 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient aged of 6 years old or more, presenting SJS/TEN, drug or infectious origin proofed and very strongly suspected (indirect certainty argument), confirmed by evaluator.
- SJS or TEN evolving since less than 7 days with a progression of the detachment or the eruption observed dating less than 48 hours.
- Patient and/or have right able to understand the objectives of the trial and having given their written consent to participate (parents for minors, have right for patients in immediate life-saving emergency).
- Patient registered with a social security scheme or benefiting from a similar scheme.
- Pregnancy test beta HCG negative for women of childbearing age
Who cannot join
- Patient weighing less than 20kg
- Chronic myeloid pathology such as myeloid leukemia or AML (acute myeloid leukemia)
- Thrombophilia or thrombotic pathology in progress
- PNN (polymorphonuclear neutrophils) > 50.000/mm3 on the CBC (Complete Blood Count) during the inclusion visit
- Administration of G-CSF or GM-CSF within 5 days of inclusion
- Patient who received cyclosporine, anti-TNFalpha or intravenous immunoglobulins or lithium in the month prior the inclusion
Show all 13Show fewer
- Pregnant or breastfeeding woman
- Patient under protective measure (safeguard measure, curatorship, guardianship) or deprived of liberty
- Patient in exclusion period after participation at other interventional clinical trial
- Known hypersensitivity to the active substance (FILGRASTIM) or to the one of the excipients (glutamine acid, sorbitol E420, Polysorbate 80)
- Patient presenting a known glucose intolerance or hereditary fructose intolerance
- Patient with a traumatic brain injury less than 24 hours
- Patient admitted with septic shock
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Département d'Anesthésie-Réanimation , Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69437
Anne-Claire LUKASZEWICZ, MD
Anne-Claire LUKASZEWICZ, MD
- Recruiting
Reference center for toxic bullous dermatoses and severe drug eruptions, Edouard Herriot Hospital, Hospices Civils de Lyon
Lyon, 69437
Benoit BEN SAID, MD, 472 117 211 ext. +33, benoit.ben-said@chu-lyon.fr
Benoit BEN SAID, MD
- Recruiting
Service de Médecine Interne, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69437
Solène POUTREL, MD
Solène POUTREL, MD
About this study
Official title: Evaluating the Therapeutic Efficacy of Filgrastim in Severe Bullous Drug Eruptions (Lyell and Stevens-Johnson Syndromes)
Toxic epidermal necrolysis (TEN) including Stevens Johnson (SJS) and Lyell syndromes represent the most severe drug eruptions. It is an allergic disorder caused by cytotoxic T lymphocytes, specific of drugs, responsible for the destruction of keratinocytes by apoptosis. Regulatory T cell (CD25 high CD4+), normally responsible for controlling the activation of cytotoxic T lymphocytes, have altered function. Despite the progress made in the pathophysiological understanding of TEN, there is currently no effective treatment.
The main symptom is bullous and skin peeling > 10% giving the appearance of great burns. The death rate is estimated between 30 and 40% due to visceral inflammatory injuries and bacterial superinfection. The risk of mortality is estimated during the initial treatment by calculating the SCORTEN (mortality>10% if SCORTEN>2, mortality>90% if SCORTEN>5). The morbidity is also very important (92% at 1 year), especially ophthalmologic with high risk of blindness...
Read more
The therapeutic potential of G-CSF (Granulocyte-Colony Stimulating Factor) in TEN is supported by several observations.
The G-CSF promotes skin healing. This has been shown in human burns, with a significant reduction in healing time under G-CSF. The mechanisms associate the growth factor effect on keratinocytes, macrophages stimulation and metalloprotease activity allowing tissue remodeling limiting sequels onset. Otherwise, healing altered in deficient G-CSF mice is corrected by the growth factor injection.
The G-CSF is an immunomodulator whose activities appear to justify use in TEN :
- Polarization of immune response to Th2 non-cytotoxic (anti Th1),
- Preferential differentiation of naive LT (T lymphocytes) in regulator LT (CD25 high CD4+) and mobilization of regulator LT of the spinal cord to altered tissues.
The G-CSF was used in a few cases of TEN with great efficacy. No data is available concerning sequels of SJS/TEN in treated patients.
This clinical trial program, by providing proof of the efficacy of filgrastim in SJS/TEN, should allow progress in care of this serious toxics diseases. In the future, it could thus reduce the significant morbidity of these syndromes with a high rate of sequelae.
- Conditions
- Rare Diseases, Toxic Epidermal Necrolyses
- Being tested
- Filgrastim, Placebo
- Keywords
- Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), Lyell's syndrome, Ganulocyte-Colony Stimulating Factor (G-CSF), Filgrastim, Randomized controlled trial (RCT)
- Medical subject headings
- Rare Diseases, Stevens-Johnson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
Also called ZARZIO
Injection of ZARZIO 30 MU/0,5mL and/or ZARZIO 48 MU/0,5mL, over a period of 5 consecutive days (1 injection per day during 30 minutes - - day 1 : set up standard treatment). The filgrastim solution will be diluted in 20 mL of 5% Glucose. The dose of ZARZIO administrated depends of the patient's weight :
- 20 to < 30kg = 0,3 mL of ZARZIO 48 MU/0,5mL (subcutaneous route)
- 30 to < 60kg = 0,5 mL of ZARZIO 30 MU/0,5mL (by IV)
- 60 to < 90kg = 0,5 mL of ZARZIO 48 MU/0,5mL (by IV)
- 90 to < 120kg = 2x0,5 mL of ZARZIO 30 MU/0,5mL (by IV)
- 120 to 150kg = 0,5 mL of ZARZIO 30 MU/0,5mL + 0,5 mL of ZARZIO 48 MU/0,5mL (by IV)
- > 150kg = 2x0,5 mL of ZARZIO 48 MU/0,5mL (by IV)
PlaceboDrug
Also called GLUCOSE 5%
Injection of 20 mL of Glucose 5% solution over a period of 5 consecutive days (1 injection per day during 30 minutes - day 1 : set up standard treatment). The dose given is equivalent to that used for filgrastim :
- 20 to < 30kg = placebo not available because the injection must be done subcutaneously so the blind cannot be respected.
- 30 to < 60kg = 20mL of Glucose 5% solution (by IV)
- 60 to < 90kg = 20mL of Glucose 5% solution (by IV)
- 90 to < 120kg = 20mL of Glucose 5% solution (by IV)
- 120 to 150kg = 20mL of Glucose 5% solution (by IV)
- > 150kg = 20mL of Glucose 5% solution (by IV)
| Study group | Role | What they receive |
|---|---|---|
| FILGRASTIM | Experimental | Standard symptomatic treatment of the SJS/NET (until the reepidermization of the patient) + ZARZIO@ (30 MU/0,5mL and/or 48 MU/0,5mL - solution of 20 ml diluted in GLUCOSE 5%) administrated by IV or subcutaneous route over a period of 5 consecutive days (1 injection per day during 30 minutes) Receives: Drug: Filgrastim |
| PLACEBO | Placebo comparator | Standard symptomatic treatment of the SJS/NET (until the reepidermization of the patient) + 20 ml GLUCOSE 5% administrated by IV route over a period of 5 consecutive days (1 injection per day during 30 minutes) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrest of the SJS/NET progression at day 5
Comparison between the 2 arms of the proportion of patients with arrest of progression of skin detachment defined by a peeled surface and/or bullous and/or associated at a NIKOLSKY sign determined according to the stable burn table - Evaluation done by the Outcomes Assessor and the adjudication committee.
Measured: On day 5 (after 5 injections of ZARZIO or PLACEBO - D0: initiation of treatment)
Secondary outcomes (11)
Arrest of the SJS/NET progression
Comparison between the 2 arms of the time until the arrest of the SJS/NET progression defined by a peeled surface and/or bullous and/or associated at a NIKOLSKY sign determined according to the stable burn table - Evaluation done by the Outcomes Assessor and the adjudication committee.
Measured: At day 3, day 7 and day 15
Complete re-epidermization
Comparison between the 2 arms of the time until the complete re-epidermization defined by the disappearance of skin rashes and return to normal skin. Evaluation done by the Outcomes Assessor and the adjudication committee.
Measured: At day 3, day 5, day 7, day 15 and day 45
Overall survival
Comparison between the 2 arms of the overall survival
Measured: Until 30 days
Overall survival
Comparison between the 2 arms of the overall survival
Measured: Until 1 year
Duration of hospitalization
Comparison between the 2 arms of the number days of hospitalization corresponding to the duration of SJS/NET episode's hospitalization.
Measured: 15 days (maximal of SJS/NET episode's hospitalization)
Premature discontinuation of experimental treatment
Number of clinical and biological adverse event leading to stop the filgrastim treatment (per patient, nature and grade of the AE (adverse event ) - repository CTCAE version 5.0)
Measured: Between day 0 and day 5
Adverse events
Comparison between the 2 arms of the number of clinical and biological adverse event (by organ systems - repository CTCAE version 5.0)..
Measured: Until 1 year
Use of systemic corticosteroid therapy
Study of the nature, cumulative doses and indications objectifying a corticosteroid prescription. A comparison between the 2 arms will be done.
Measured: Between day 0 and day 15
Evaluation of sequels
Determination of the proportion of patients with at least one sequel among the following specialty : ophthalmology, stomatology/ORL(otorhinolaryngology), gastroenterology, gynecology, urology and psychiatry, researched during specialized consultations during the remote monitoring phase. A comparison between the 2 arms will be done.
Measured: At day 45, day 60, day 90, day 180 and 1 year
Quality of life evolution
Quality of life evolution assessed with Dermatology Life Quality Index (DLQI) or Children's Dermatology Life Quality Index (CDLQI).
DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
CDLQI is used in the same way. It is documented in 5 minutes. Each question is illustrated by a cartoon based on the theme of the question, making it more fun for younger children. The scoring for each question is "Very much"[Score = 3], "Quite a lot"[2], "Only a little"[1], "Not at all"[0], "Blank"[0], and Q7 - "prevented school"[3]. The 10 individual question scores are summed to provide a total CDLQI score. The maximum possible score is 30, indicating maximum impact on QoL.
A comparison between the 2 arms will be done.
Measured: At day 60, day 180 and 1 year
Risk of developing Post Traumatic Stress Disorder (PTSD)
Determination of the proportion of patients with high risk of developing PTSD measured with Impact of Event Scale Revised (IES-R) or Children's Revised Impact of Event Scale (CRIES).
IES-R is a 22-item self-administered questionnaire that measures symptoms of intrusion, avoidance and over-arousal experienced during the past 7 days. Patients rate each item on a 0-5 point Likert scale. The total score, between 0 and 88, is obtained by adding all the ratings for each item: low risk (score less than 12), moderate (score between 12 and 34 inclusive) or at high risk (score strictly greater than 34) of developing PTSD.
CRIES-13 is a revised scale to measure the impact of events on children from 8 years old. Items are rated on a 4-point scale, with scores of 0, 1, 3 and 5 points. The maximum score is 65. The score is obtained by adding the responses to each item. A score of 30 or more would be effective in screening for PTSD.
A comparison between the 2 arms will be done.
Measured: At day 0, day 7 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start13 May 2022
- Primary completion18 May 2025 (estimated)
- Study completion13 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651439
- Sponsor's protocol ID
- 69HCL19_0375
- Acronym
- GNET
- Status last verified
- May 2024
- First submitted
- 25 Nov 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Therapeutic Efficacy of Filgrastim in Severe Bullous Drug Eruptions (Lyell and Stevens-Johnson Syndromes)
- ClinicalTrials.gov ID
- NCT04651439
- Acronym / sponsor ID
- GNET / 69HCL19_0375
- Conditions
- Rare Diseases, Toxic Epidermal Necrolyses
- Keywords
- Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), Lyell's syndrome, Ganulocyte-Colony Stimulating Factor (G-CSF), Filgrastim, Randomized controlled trial (RCT)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 18 May 2025 (estimated)
- Study completion
- 13 May 2026 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Toxic epidermal necrolysis (TEN) including Stevens Johnson (SJS) and Lyell syndromes represent the most severe drug eruptions. It is an allergic disorder caused by cytotoxic T lymphocytes, specific of drugs, responsible for the destruction of keratinocytes by apoptosis. Regulatory T cell (CD25 high CD4+), normally responsible for controlling the activation of cytotoxic T lymphocytes, have altered function. Despite the progress made in the pathophysiological understanding of TEN, there is currently no effective treatment.
The main symptom is bullous and skin peeling > 10% giving the appearance of great burns. The death rate is estimated between 30 and 40% due to visceral inflammatory injuries and bacterial superinfection. The risk of mortality is estimated during the initial treatment by calculating the SCORTEN (mortality>10% if SCORTEN>2, mortality>90% if SCORTEN>5). The morbidity is also very important (92% at 1 year), especially ophthalmologic with high risk of blindness...
The therapeutic potential of G-CSF (Granulocyte-Colony Stimulating Factor) in TEN is supported by several observations.
The G-CSF promotes skin healing. This has been shown in human burns, with a significant reduction in healing time under G-CSF. The mechanisms associate the growth factor effect on keratinocytes, macrophages stimulation and metalloprotease activity allowing tissue remodeling limiting sequels onset. Otherwise, healing altered in deficient G-CSF mice is corrected by the growth factor injection.
The G-CSF is an immunomodulator whose activities appear to justify use in TEN :
- Polarization of immune response to Th2 non-cytotoxic (anti Th1),
- Preferential differentiation of naive LT (T lymphocytes) in regulator LT (CD25 high CD4+) and mobilization of regulator LT of the spinal cord to altered tissues.
The G-CSF was used in a few cases of TEN with great efficacy. No data is available concerning sequels of SJS/TEN in treated patients.
This clinical trial program, by providing proof of the efficacy of filgrastim in SJS/TEN, should allow progress in care of this serious toxics diseases. In the future, it could thus reduce the significant morbidity of these syndromes with a high rate of sequelae.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FILGRASTIM | Experimental | Drug: FilgrastimStandard symptomatic treatment of the SJS/NET (until the reepidermization of the patient) + ZARZIO@ (30 MU/0,5mL and/or 48 MU/0,5mL - solution of 20 ml diluted in GLUCOSE 5%) administrated by IV or subcutaneous route over a period of 5 consecutive days (1 injection per day during 30 minutes) |
| PLACEBO | Placebo comparator | Drug: PlaceboStandard symptomatic treatment of the SJS/NET (until the reepidermization of the patient) + 20 ml GLUCOSE 5% administrated by IV route over a period of 5 consecutive days (1 injection per day during 30 minutes) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged of 6 years old or more, presenting SJS/TEN, drug or infectious origin proofed and very strongly suspected (indirect certainty argument), confirmed by evaluator.
- SJS or TEN evolving since less than 7 days with a progression of the detachment or the eruption observed dating less than 48 hours.
- Patient and/or have right able to understand the objectives of the trial and having given their written consent to participate (parents for minors, have right for patients in immediate life-saving emergency).
- Patient registered with a social security scheme or benefiting from a similar scheme.
- Pregnancy test beta HCG negative for women of childbearing age
Key exclusion criteria (13 listed)
- Patient weighing less than 20kg
- Chronic myeloid pathology such as myeloid leukemia or AML (acute myeloid leukemia)
- Thrombophilia or thrombotic pathology in progress
- PNN (polymorphonuclear neutrophils) > 50.000/mm3 on the CBC (Complete Blood Count) during the inclusion visit
- Administration of G-CSF or GM-CSF within 5 days of inclusion
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 |
|---|---|---|
| FilgrastimAlso: ZARZIOInjection of ZARZIO 30 MU/0,5mL and/or ZARZIO 48 MU/0,5mL, over a period of 5 consecutive days (1 injection per day during 30 minutes - - day 1 : set up standard treatment). The filgrastim solution will be diluted in 20 mL of 5% Glucose. The dose of ZARZIO administrated depends of the patient's weight : * 20 to < 30kg = 0,3 mL of ZARZIO 48 MU/0,5mL (subcutaneous route) * 30 to < 60kg = 0,5 mL of ZARZIO 30 MU/0,5mL (by IV) * 60 to < 90kg = 0,5 mL of ZARZIO 48 MU/0,5mL (by IV) * 90 to < 120kg = 2x0,5 mL of ZARZIO 30 MU/0,5mL (by IV) * 120 to 150kg = 0,5 mL of ZARZIO 30 MU/0,5mL + 0,5 mL of ZARZIO 48 MU/0,5mL (by IV) * > 150kg = 2x0,5 mL of ZARZIO 48 MU/0,5mL (by IV) | Drug | FILGRASTIM |
| PlaceboAlso: GLUCOSE 5%Injection of 20 mL of Glucose 5% solution over a period of 5 consecutive days (1 injection per day during 30 minutes - day 1 : set up standard treatment). The dose given is equivalent to that used for filgrastim : * 20 to < 30kg = placebo not available because the injection must be done subcutaneously so the blind cannot be respected. * 30 to < 60kg = 20mL of Glucose 5% solution (by IV) * 60 to < 90kg = 20mL of Glucose 5% solution (by IV) * 90 to < 120kg = 20mL of Glucose 5% solution (by IV) * 120 to 150kg = 20mL of Glucose 5% solution (by IV) * > 150kg = 20mL of Glucose 5% solution (by IV) | Drug | PLACEBO |
Primary outcome
Arrest of the SJS/NET progression at day 5
Time frame: On day 5 (after 5 injections of ZARZIO or PLACEBO - D0: initiation of treatment)
Comparison between the 2 arms of the proportion of patients with arrest of progression of skin detachment defined by a peeled surface and/or bullous and/or associated at a NIKOLSKY sign determined according to the stable burn table - Evaluation done by the Outcomes Assessor and the adjudication committee.
11 secondary outcomes
Arrest of the SJS/NET progression
Time frame: At day 3, day 7 and day 15
Complete re-epidermization
Time frame: At day 3, day 5, day 7, day 15 and day 45
Overall survival
Time frame: Until 30 days
Overall survival
Time frame: Until 1 year
Duration of hospitalization
Time frame: 15 days (maximal of SJS/NET episode's hospitalization)
Premature discontinuation of experimental treatment
Time frame: Between day 0 and day 5
Adverse events
Time frame: Until 1 year
Use of systemic corticosteroid therapy
Time frame: Between day 0 and day 15
Evaluation of sequels
Time frame: At day 45, day 60, day 90, day 180 and 1 year
Quality of life evolution
Time frame: At day 60, day 180 and 1 year
Risk of developing Post Traumatic Stress Disorder (PTSD)
Time frame: At day 0, day 7 and day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Filgrastim in people with Rare Diseases and Toxic Epidermal Necrolyses, run by Hospices Civils de Lyon at 3 sites in France.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benoit BEN SAID, MD (472 117 211 ext. +33, benoit.ben-said@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrest of the SJS/NET progression at day 5 (time frame: On day 5 (after 5 injections of ZARZIO or PLACEBO - D0: initiation of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.