Underdose (Unintentional)Phase 1NCT01919710
Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia
A Phase 1 study testing rHSA/GCSF in people with Underdose (Unintentional) and Cancer, run by Tianjin SinoBiotech Ltd. at 1 site in China.
Trial summary
Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of neutropenia induced by chemotherapy of cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Underdose (Unintentional), Cancer, Tumor
- What is being tested?
- rHSA/GCSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Aug 2014
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chemotherapy induced neutropenia
Who cannot join
- treated with other biological drugs or other neutropenia therapy drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of rHSA/GCSF in Neutropenia After Chemotherapy of Cancer Patients
Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of neutropenia induced by chemotherapy of cancer patients.
Read the detailed description
A dosage climbing for the safety and efficacy studies for the neutropenia induced by chemotherapy cancer patients Repeat-dose studies for the safety and efficacy studied for the neutropenia.
- Conditions
- Underdose (Unintentional), Cancer, Tumor
- Being tested
- rHSA/GCSF
- Keywords
- Neutropenia, chemotherapy, rHSA/GCSF
- Medical subject headings
- Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rHSA/GCSFDrug
Also called Long acting rhG-CSF fusion protein
for treatment of neutropenia
| Study group | Role | What they receive |
|---|---|---|
| rHSA/GCSF for injection | Experimental | rHSA/GCSF Start from 300mcg Receives: Drug: rHSA/GCSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of participants with adverse events as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
Measured: 14 days
Secondary outcomes (1)
AUC
AUC after single and multiple dose of rHSA/GCSF
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underdose (Unintentional)Studies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin SinoBiotech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
- Investigators
- Jun ZHU, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919710
- Sponsor's protocol ID
- 9314-rHSA/GCSF
- Other IDs
- 2011L01837
- Status last verified
- Jun 2015
- First submitted
- 26 Nov 2012
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of rHSA/GCSF in Neutropenia After Chemotherapy of Cancer Patients
- ClinicalTrials.gov ID
- NCT01919710
- Acronym / sponsor ID
- 9314-rHSA/GCSF
- Conditions
- Underdose (Unintentional), Cancer, Tumor
- Keywords
- Neutropenia, chemotherapy, rHSA/GCSF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Tianjin SinoBiotech Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- Oct 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Aug 2013 (estimated)
- 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.
Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of neutropenia induced by chemotherapy of cancer patients.
Detailed description
A dosage climbing for the safety and efficacy studies for the neutropenia induced by chemotherapy cancer patients Repeat-dose studies for the safety and efficacy studied for the neutropenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rHSA/GCSF for injection | Experimental | Drug: rHSA/GCSFrHSA/GCSF Start from 300mcg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chemotherapy induced neutropenia
Key exclusion criteria (1 listed)
- treated with other biological drugs or other neutropenia therapy drugs
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 |
|---|---|---|
| rHSA/GCSFAlso: Long acting rhG-CSF fusion proteinfor treatment of neutropenia | Drug | rHSA/GCSF for injection |
Primary outcome
Number of adverse events
Time frame: 14 days
Number of participants with adverse events as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
1 secondary outcome
AUC
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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.
Jun ZHU, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rHSA/GCSF in people with Underdose (Unintentional) and Cancer, run by Tianjin SinoBiotech Ltd. at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 3 Jun 2015. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of adverse events (time frame: 14 days). 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 3 Jun 2015.