Growth DisordersRAZANTNCT03274973

Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome

An observational study of Growth Disorders, run by Ferring Pharmaceuticals at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Assessment of long-term effectiveness of ZOMACTON in treatment of Growth Hormone Deficiency or growth retardation due to Ullrich-Turner Syndrome and assessment of compliance and adherence, optionally with the aid of an electronic app or patient diary. Read more about this study

Who is it for?: Ages Up to 18 years
Conditions the study is for: Growth Disorders
What is being tested?: Zomacton
Type of treatment: Injection or infusion
How many people: 4 participants
Where: 1 siteGermany
Study dates: 14 May 2018to 31 Oct 2018
Phase: Observational
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 Up to 18 years
All sexes
No healthy volunteers
Child, Adult

Study population: Pediatric outpatient clinic

Who may be able to join

Pediatric patients (< 18 years) with growth hormone deficiency or growth retardation due to Ullrich-Turner-Syndrome
Patients already receiving or who have been prescribed Zomacton® de novo according to its German label; the decision to prescribe Zomacton® was made independently from participation and prior to enrollment in this study.
Patient and their parents (or legal representatives) who are willing and able to provide signed informed consent for use of their personal data.

Who cannot join

Participation in an interventional clinical study within the last 30 days prior to baseline visit or during the follow-up period

Trial locations and contacts

1 site in 1 country.

Germany1 site

Klinik fuer Allgemeine Paediatrie der Christian-Albrechts-Universitaet zu Kiel (there might be other sites in this country)
Kiel, 24105

Other trials in Germany

About this study

Official title: A Prospective Non-Interventional Study to Assess Long-term Effectiveness of Zomacton® and Factors Affecting Adherence in Patients With Growth Hormone Deficiency or Growth Retardation Due to Ullrich-Turner Syndrome

Conditions: Growth Disorders
Being tested: Zomacton
Medical subject headings: Growth Disorders

What participants receive

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

ZomactonDrug
Injection

Study groups in NCT03274973
Study group	Role	What they receive
Zomacton		Not described Receives: Drug: Zomacton

What is being measured

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

Linear growth (change in height)
Change in height defined as the change of the standard deviation score of body height vs. baseline
Measured: Over the first 12 months (month 0, 3, 6, 9 and 12)

Timeline

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

14 May 201831 Oct 2018

First posted7 Sep 2017
Study start14 May 2018
Primary completion31 Oct 2018
Study completion31 Oct 2018

Why it stopped: Insufficient, delayed recruitment of participants

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Growth DisordersStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03274973
Sponsor's protocol ID: 000302
Acronym: RAZANT
Status last verified: Dec 2018
First submitted: 29 Aug 2017
Last updated: 13 Dec 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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

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All Growth Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Non-Interventional Study to Assess Long-term Effectiveness of Zomacton® and Factors Affecting Adherence in Patients With Growth Hormone Deficiency or Growth Retardation Due to Ullrich-Turner Syndrome
ClinicalTrials.gov ID: NCT03274973
Acronym / sponsor ID: RAZANT / 000302
Conditions: Growth Disorders
Study type: Observational
Recruitment status: TerminatedReason stopped: Insufficient, delayed recruitment of participants
Enrolment: 4 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 14 May 2018 (actual)
Primary completion: 31 Oct 2018 (actual)
Study completion: 31 Oct 2018 (actual)
First posted: 7 Sep 2017 (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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Zomacton	–	Drug: Zomacton

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Pediatric outpatient clinic

Key inclusion criteria (3 listed)

Pediatric patients (< 18 years) with growth hormone deficiency or growth retardation due to Ullrich-Turner-Syndrome
Patients already receiving or who have been prescribed Zomacton® de novo according to its German label; the decision to prescribe Zomacton® was made independently from participation and prior to enrollment in this study.
Patient and their parents (or legal representatives) who are willing and able to provide signed informed consent for use of their personal data.

Key exclusion criteria (1 listed)

Participation in an interventional clinical study within the last 30 days prior to baseline visit or during the follow-up period

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
ZomactonInjection	Drug	Zomacton

Primary outcome

Linear growth (change in height)
Time frame: Over the first 12 months (month 0, 3, 6, 9 and 12)
Change in height defined as the change of the standard deviation score of body height vs. baseline

Results and safety

The study was stopped early (reason given: Insufficient, delayed recruitment of participants). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.

Related trials for Growth Disorders

Recruiting
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Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 1/2
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
EGFR-Mutant Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
Not yet recruitingPhase 3
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Androgenetic Alopecia, Androgenetic Alopecia (AGA)

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.

Global Clinical Compliance study director

Ferring Pharmaceuticals

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

Questions about this trial

What is this clinical trial studying?

An observational study of Growth Disorders, run by Ferring Pharmaceuticals at 1 site in Germany.

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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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.

Are results available for this study?

The study was stopped early (reason given: Insufficient, delayed recruitment of participants). Results are not available in the source record.

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?

Linear growth (change in height) (time frame: Over the first 12 months (month 0, 3, 6, 9 and 12)). 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 NCT03274973.

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 13 Dec 2018.