HepatitisNCT00679692
Evaluation the Growth Factors(IGF-1,IGFBP-3and HGH)in Patients With Chronic Liver Disease
An observational study of Hepatitis and Liver Cirrhosis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
BACKGROUND The insulin-like growth factor system (IGFs) plays an important role in cell growth and differentiation. Nevertheless, the roles played by insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone (HGH) in the progression of chronic liver disease… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis, Liver Cirrhosis, Hepatocellular Carcinoma
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2006to Mar 2008
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute hepatitis liver cirrhosis hepatocellular carcinoma
Who may be able to join
- Clinical diagnosis of Hepatocellular carcinoma
- Must be primary Hepatocellular carcinoma and untreament
Who cannot join
- treatment Hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Radio immunoassay lab,Department of Nuclear Medical University Hospital,No.100 Tzyou 1st Road
Kaohsiung City
About this study
Official title: Insulin-Like Growth Factor-1,Insulin-Like Growth Factor Binding Protein-3 and Human Growth Hormone in Serum of Patients With Chronic Liver Disease and Possible Clinical Applications.
BACKGROUND The insulin-like growth factor system (IGFs) plays an important role in cell growth and differentiation. Nevertheless, the roles played by insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone (HGH) in the progression of chronic liver disease remain to be elucidated and investigated.
METHODS The subjects in the present study included 60 healthy controls, 30 hepatitis patients, 60 liver cirrhosis patients and 60 untreated hepatocellular carcinoma patients. Blood was drawn by venipuncture into Venoject tubes. To find the possible correlations between liver damage and IGFs, serum IGF-1, GH, IGFBP-3 concentration and related biochemical parameters were measured. We used immunoradiometric assay to determine the levels of IGF-1, HGH and IGFBP-3 in serum.
Read the detailed description
healthy controls:one blood sample (7.5 cc) hepatitis: three blood samples, at admission, at 3rd and 7-10th day of admission liver cirrhosis: two blood samples, at 1-2 years interval (7.5 cc/each session) hepatocellular carcinoma: three blood samples, before, 1 day after and at the 7th day of transcatheter arterial chembolizatiom
- Conditions
- Hepatitis, Liver Cirrhosis, Hepatocellular Carcinoma
- Keywords
- GH,IGF-1, IGFBP-3
- Medical subject headings
- Hepatitis, Liver Cirrhosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 3: | three arms for study |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startSep 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- chiou m Lin, Ms, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679692
- Sponsor's protocol ID
- KMUH-IRB-950123
- Other IDs
- KMUH-IRB-950123
- Status last verified
- Jan 2006
- First submitted
- 15 May 2008
- Last updated
- 19 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin-Like Growth Factor-1,Insulin-Like Growth Factor Binding Protein-3 and Human Growth Hormone in Serum of Patients With Chronic Liver Disease and Possible Clinical Applications.
- ClinicalTrials.gov ID
- NCT00679692
- Acronym / sponsor ID
- KMUH-IRB-950123
- Conditions
- Hepatitis, Liver Cirrhosis, Hepatocellular Carcinoma
- Keywords
- GH,IGF-1, IGFBP-3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 May 2008 (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.
BACKGROUND The insulin-like growth factor system (IGFs) plays an important role in cell growth and differentiation. Nevertheless, the roles played by insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone (HGH) in the progression of chronic liver disease remain to be elucidated and investigated.
METHODS The subjects in the present study included 60 healthy controls, 30 hepatitis patients, 60 liver cirrhosis patients and 60 untreated hepatocellular carcinoma patients. Blood was drawn by venipuncture into Venoject tubes. To find the possible correlations between liver damage and IGFs, serum IGF-1, GH, IGFBP-3 concentration and related biochemical parameters were measured. We used immunoradiometric assay to determine the levels of IGF-1, HGH and IGFBP-3 in serum.
Detailed description
healthy controls:one blood sample (7.5 cc) hepatitis: three blood samples, at admission, at 3rd and 7-10th day of admission liver cirrhosis: two blood samples, at 1-2 years interval (7.5 cc/each session) hepatocellular carcinoma: three blood samples, before, 1 day after and at the 7th day of transcatheter arterial chembolizatiom
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3: | – | –three arms for study |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute hepatitis liver cirrhosis hepatocellular carcinoma
Key inclusion criteria (2 listed)
- Clinical diagnosis of Hepatocellular carcinoma
- Must be primary Hepatocellular carcinoma and untreament
Key exclusion criteria (1 listed)
- treatment Hepatocellular carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 19 May 2008.
Related trials for Hepatitis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
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.
chiou m Lin, Ms principal investigator
Kaohsiung Medical University
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 Hepatitis and Liver Cirrhosis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 2 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 19 May 2008. 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 Taiwan. 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 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.
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 19 May 2008.