Alpha-1-antitrypsin DeficiencyPhase 2CBZNCT01379469

Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency

A Phase 2 study testing Drug-Carbamazepine (Tegretol XR) in people with Alpha-1-antitrypsin Deficiency and Liver Cirrhosis, run by Washington University School of Medicine at 3 sites in United States.

Terminated

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

Official record

Search all trials

Trial summary

The primary objective is to determine if the medication Carbamazepine, can be used as a therapy for patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency . Read more about this study

Who is it for?: Ages 14 to 80 years
Conditions the study is for: Alpha-1-antitrypsin Deficiency, Liver Cirrhosis
What is being tested?: Drug-Carbamazepine (Tegretol XR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 3 sitesUnited States
Study dates: Jan 2012to Feb 2017
Phase: Phase 2
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 14 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age greater than or equal to 14 years to less than or equal to 80 years of age.
Alpha-1-Antitrypsin deficiency confirmed by ZZ or SZ phenotype \& serum level
< 83mg/dl.
HVPG greater than or equal to 10 mmHg unless collateral vessels are visualized via transvenous biopsy.

Who cannot join

Child Pugh Score greater than or equal to 12. Serum total bilirubin > 5 mg/dl. INR > 2.2.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Children's Hospital of Pittsburgh, UPMC
Pittsburgh, Pennsylvania, 15201
University of Pittsburgh Medical Center, Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Preliminary Study of the Efficacy and Safety of Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency

The primary objective is to determine if the medication Carbamazepine, can be used as a therapy for patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency .

Read the detailed description

The primary objective is to determine if Carbamazepine therapy in patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency leads to a significant reduction in the hepatic accumulation of ATZ.

The other objectives are:

To determine whether Carbamazepine treatment reduces hepatic fibrosis in alpha-1-antitrypsin deficient patients with severe liver disease. To determine whether Carbamazepine treatment reduces portal pressure in alpha-1-antitrypsin deficient patients with severe liver disease. To determine whether Carbamazepine treatment is safe and tolerated by patients with severe liver disease caused by alpha-1-deficiency. To determine whether Carbamazepine treatment leads to stabilization in disease severity as measured by the MELD scores.

Conditions: Alpha-1-antitrypsin Deficiency, Liver Cirrhosis
Being tested: Drug-Carbamazepine (Tegretol XR), Carbamazepine (Tegretol XR) Placebo
Keywords: Carbamazepine (Tegretol) use, severe liver disease, alpha-1-antitrypsin deficiency
Medical subject headings: alpha 1-Antitrypsin Deficiency, Liver Cirrhosis, Liver Diseases

What participants receive

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

Drug-Carbamazepine (Tegretol XR)Drug
Also called Tegretol-XR Carbamazepine extended release tablets., NDC 0078-0510-05.
To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated..
Carbamazepine (Tegretol XR) PlaceboDrug
Also called Carbamazepine (Tegretol-XR) placebo.
Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine.

Study groups in NCT01379469
Study group	Role	What they receive
Drug-Carbamazepine (Tegretol XR)	Active comparator	One arm receives Drug-Carbamazepine (Tegretol XR).All subjects have severe liver disease due to alpha-1-antitrypsin deficiency. Receives: Drug: Drug-Carbamazepine (Tegretol XR)
Drug-Carbamazepine (Tegretol XR) Placebo	Placebo comparator	One arm receives Carbamazepine (Tegretol-XR) placebo.All subjects have severe liver disease due to alpha-1-antitrypsin deficiency. Receives: Drug: Carbamazepine (Tegretol XR) Placebo

What is being measured

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

The Primary Outcome Will be to Determine the Effect of Carbamazepine on Hepatic ATZ Load.
The effect of Carbamazepine on hepatic ATZ load will be measured by the number of hepatocytes with PAS+/diastase-resistant globules and/or steady state levels of ATZ by immunoblot analysis.
Measured: 52 weeks

Secondary outcomes (1)

For the Secondary Outcomes we Will Determine the Effect of Carbamazepine Treatment on Hepatic Fibrosis.
For the secondary outcomes we will determine the effect of Carbamazepine treatment on hepatic fibrosis on the basis of sirius red staining and hydroxyproline concentration and whether Carbamazepine treatment changes portal pressure as determined by Hepatic Venous Pressure Gradient.
Measured: 52 weeks

Timeline

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

Jan 2012Feb 2017

First posted23 Jun 2011 (estimated)
Study startJan 2012
Primary completionFeb 2017
Study completionFeb 2017

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.
Publications (48)Papers the sponsor has linked to this study.
Other trials for Alpha-1-antitrypsin DeficiencyStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01379469
Sponsor's protocol ID: 201510060-PRO09070279
Other IDs: 1R21DK092567-01
Acronym: CBZ
Status last verified: Oct 2021
First submitted: 15 Jun 2011
Last updated: 12 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: We will share data and liver tissue with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. We may also share research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at the information.

Publications

Perlmutter D.H., Alpha-1-Antitrypsin Deficiency, in Schiff's Disease of Liver, Schiff E.R., Maddrey W.C., Editor. 2007; Lippincott-Raven: Philadelphia. 1063-1084.
Perlmutter DH. Pathogenesis of chronic liver injury and hepatocellular carcinoma in alpha-1-antitrypsin deficiency. Pediatr Res. 2006 Aug;60(2):233-8. doi: 10.1203/01.pdr.0000228350.61496.90.
PubMed 16864711
Perlmutter DH. Autophagic disposal of the aggregation-prone protein that causes liver inflammation and carcinogenesis in alpha-1-antitrypsin deficiency. Cell Death Differ. 2009 Jan;16(1):39-45. doi: 10.1038/cdd.2008.103. Epub 2008 Jul 11.
PubMed 18617899
Rudnick DA, Perlmutter DH. Alpha-1-antitrypsin deficiency: a new paradigm for hepatocellular carcinoma in genetic liver disease. Hepatology. 2005 Sep;42(3):514-21. doi: 10.1002/hep.20815.
PubMed 16044402
Piitulainen E, Carlson J, Ohlsson K, Sveger T. Alpha1-antitrypsin deficiency in 26-year-old subjects: lung, liver, and protease/protease inhibitor studies. Chest. 2005 Oct;128(4):2076-81. doi: 10.1378/chest.128.4.2076.
PubMed 16236857
Sveger T. Liver disease in alpha1-antitrypsin deficiency detected by screening of 200,000 infants. N Engl J Med. 1976 Jun 10;294(24):1316-21. doi: 10.1056/NEJM197606102942404.
PubMed 1083485
Eriksson S, Carlson J, Velez R. Risk of cirrhosis and primary liver cancer in alpha 1-antitrypsin deficiency. N Engl J Med. 1986 Mar 20;314(12):736-9. doi: 10.1056/NEJM198603203141202.
PubMed 3485248
Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973 Aug;60(8):646-9. doi: 10.1002/bjs.1800600817. No abstract available.
PubMed 4541913
Malinchoc M, Kamath PS, Gordon FD, Peine CJ, Rank J, ter Borg PC. A model to predict poor survival in patients undergoing transjugular intrahepatic portosystemic shunts. Hepatology. 2000 Apr;31(4):864-71. doi: 10.1053/he.2000.5852.
PubMed 10733541
Burroughs AK, Thalheimer U. Hepatic venous pressure gradient in 2010: optimal measurement is key. Hepatology. 2010 Jun;51(6):1894-6. doi: 10.1002/hep.23710. No abstract available.
PubMed 20512984
Zoli M, Iervese T, Merkel C, Bianchi G, Magalotti D, Marchesini G, Gatta A, Pisi E. Prognostic significance of portal hemodynamics in patients with compensated cirrhosis. J Hepatol. 1993 Jan;17(1):56-61. doi: 10.1016/s0168-8278(05)80521-5.
PubMed 8445220
Manolakopoulos S, Triantos C, Theodoropoulos J, Vlachogiannakos J, Kougioumtzan A, Papatheodoridis G, Tzourmakliotis D, Karamanolis D, Burroughs AK, Archimandritis A, Raptis S, Avgerinos A. Antiviral therapy reduces portal pressure in patients with cirrhosis due to HBeAg-negative chronic hepatitis B and significant portal hypertension. J Hepatol. 2009 Sep;51(3):468-74. doi: 10.1016/j.jhep.2009.05.031. Epub 2009 Jul 3.
PubMed 19616339
Roberts S, Gordon A, McLean C, Pedersen J, Bowden S, Thomson K, Angus P. Effect of sustained viral response on hepatic venous pressure gradient in hepatitis C-related cirrhosis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):932-7. doi: 10.1016/j.cgh.2007.02.022. Epub 2007 Jun 4.
PubMed 17544878
Hidvegi T., Perlmutter D.H., Watkins S., and Michalopoulos G., Carbamazepine ameliorates liver disease in mouse models of alpha-1-antitrypsin deficiency by enhancing intracellular disposal of the pathogenic aggregation-prone protein. Science; 2010; 329: 229-232.
Dodson W., Carbamazepine and oxycarbazepine, Pediatric Epilepsy: Diagnosis and Therapy, P.J. Dodson W.E., Editor. 1993; Demos Publications: New York. 303-314.

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 Alpha-1-antitrypsin Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Preliminary Study of the Efficacy and Safety of Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency
ClinicalTrials.gov ID: NCT01379469
Acronym / sponsor ID: CBZ / 201510060-PRO09070279
Conditions: Alpha-1-antitrypsin Deficiency, Liver Cirrhosis
Keywords: Carbamazepine (Tegretol) use, severe liver disease, alpha-1-antitrypsin deficiency
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 20 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Novartis, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pittsburgh
Study start: Jan 2012
Primary completion: Feb 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 23 Jun 2011 (estimated)
Results: Posted 12 Oct 2021

Clinical summary

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

The primary objective is to determine if the medication Carbamazepine, can be used as a therapy for patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency .

Detailed description

The other objectives are:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Drug-Carbamazepine (Tegretol XR)	Active comparator	Drug: Drug-Carbamazepine (Tegretol XR)One arm receives Drug-Carbamazepine (Tegretol XR).All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.
Drug-Carbamazepine (Tegretol XR) Placebo	Placebo comparator	Drug: Carbamazepine (Tegretol XR) PlaceboOne arm receives Carbamazepine (Tegretol-XR) placebo.All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.

Who may qualify

Ages: 14 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Age greater than or equal to 14 years to less than or equal to 80 years of age.
Alpha-1-Antitrypsin deficiency confirmed by ZZ or SZ phenotype \& serum level
< 83mg/dl.
HVPG greater than or equal to 10 mmHg unless collateral vessels are visualized via transvenous biopsy.

Key exclusion criteria (1 listed)

Child Pugh Score greater than or equal to 12. Serum total bilirubin > 5 mg/dl. INR > 2.2.

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
Drug-Carbamazepine (Tegretol XR)Also: Tegretol-XR Carbamazepine extended release tablets., NDC 0078-0510-05.To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated..	Drug	Drug-Carbamazepine (Tegretol XR)
Carbamazepine (Tegretol XR) PlaceboAlso: Carbamazepine (Tegretol-XR) placebo.Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine.	Drug	Drug-Carbamazepine (Tegretol XR) Placebo

Primary outcome

The Primary Outcome Will be to Determine the Effect of Carbamazepine on Hepatic ATZ Load.
Time frame: 52 weeks
The effect of Carbamazepine on hepatic ATZ load will be measured by the number of hepatocytes with PAS+/diastase-resistant globules and/or steady state levels of ATZ by immunoblot analysis.

1 secondary outcome

For the Secondary Outcomes we Will Determine the Effect of Carbamazepine Treatment on Hepatic Fibrosis.
Time frame: 52 weeks

Results and safety

Results posted to the registry on 12 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drug-Carbamazepine (Tegretol XR)	13	1
Drug-Carbamazepine (Tegretol XR) Placebo	7	3

Primary outcome: The Primary Outcome Will be to Determine the Effect of Carbamazepine on Hepatic ATZ Load.

Time frame: 52 weeks

Population analysed: The primary outcome was not assessable because the number of subjects with available pre \& post PAS+/diastase stained liver biopsies \& tissue for immunoblot was insufficient in subject number and sample quality. To elaborate only 3 subjects had both pre \& post biopsies stained for PAS, 2 from the placebo \& 1 from the Carbamazepine arms \& the available histology quality was insufficient for histomorphormetry. Frozen liver samples were also of insufficient number \& mass for immunoblot.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious Adverse Events and Adverse Events were collected for 52 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drug-Carbamazepine (Tegretol XR)	6 of 13 (46.2%)	13 of 13 (100%)	0 of 13
Drug-Carbamazepine (Tegretol XR) Placebo	4 of 7 (57.1%)	7 of 7 (100%)	2 of 7

Limitations and caveats (from the sponsor): The primary \& secondary outcomes could not be assessed because the number of subjects with available pre \& post biopsies was insufficient in subject number and sample quality to conduct the analyses. As described in more detail in Outcome Measures. .

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundPerlmutter D.H., Alpha-1-Antitrypsin Deficiency, in Schiff's Disease of Liver, Schiff E.R., Maddrey W.C., Editor. 2007; Lippincott-Raven: Philadelphia. 1063-1084.
Background: PubMed 16864711Perlmutter DH. Pathogenesis of chronic liver injury and hepatocellular carcinoma in alpha-1-antitrypsin deficiency. Pediatr Res. 2006 Aug;60(2):233-8. doi: 10.1203/01.pdr.0000228350.61496.90.
Background: PubMed 18617899Perlmutter DH. Autophagic disposal of the aggregation-prone protein that causes liver inflammation and carcinogenesis in alpha-1-antitrypsin deficiency. Cell Death Differ. 2009 Jan;16(1):39-45. doi: 10.1038/cdd.2008.103. Epub 2008 Jul 11.
Background: PubMed 16044402Rudnick DA, Perlmutter DH. Alpha-1-antitrypsin deficiency: a new paradigm for hepatocellular carcinoma in genetic liver disease. Hepatology. 2005 Sep;42(3):514-21. doi: 10.1002/hep.20815.
Background: PubMed 16236857Piitulainen E, Carlson J, Ohlsson K, Sveger T. Alpha1-antitrypsin deficiency in 26-year-old subjects: lung, liver, and protease/protease inhibitor studies. Chest. 2005 Oct;128(4):2076-81. doi: 10.1378/chest.128.4.2076.
Background: PubMed 1083485Sveger T. Liver disease in alpha1-antitrypsin deficiency detected by screening of 200,000 infants. N Engl J Med. 1976 Jun 10;294(24):1316-21. doi: 10.1056/NEJM197606102942404.
Background: PubMed 3485248Eriksson S, Carlson J, Velez R. Risk of cirrhosis and primary liver cancer in alpha 1-antitrypsin deficiency. N Engl J Med. 1986 Mar 20;314(12):736-9. doi: 10.1056/NEJM198603203141202.
Background: PubMed 4541913Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973 Aug;60(8):646-9. doi: 10.1002/bjs.1800600817. No abstract available.
Background: PubMed 10733541Malinchoc M, Kamath PS, Gordon FD, Peine CJ, Rank J, ter Borg PC. A model to predict poor survival in patients undergoing transjugular intrahepatic portosystemic shunts. Hepatology. 2000 Apr;31(4):864-71. doi: 10.1053/he.2000.5852.
Background: PubMed 20512984Burroughs AK, Thalheimer U. Hepatic venous pressure gradient in 2010: optimal measurement is key. Hepatology. 2010 Jun;51(6):1894-6. doi: 10.1002/hep.23710. No abstract available.
Background: PubMed 8445220Zoli M, Iervese T, Merkel C, Bianchi G, Magalotti D, Marchesini G, Gatta A, Pisi E. Prognostic significance of portal hemodynamics in patients with compensated cirrhosis. J Hepatol. 1993 Jan;17(1):56-61. doi: 10.1016/s0168-8278(05)80521-5.
Background: PubMed 19616339Manolakopoulos S, Triantos C, Theodoropoulos J, Vlachogiannakos J, Kougioumtzan A, Papatheodoridis G, Tzourmakliotis D, Karamanolis D, Burroughs AK, Archimandritis A, Raptis S, Avgerinos A. Antiviral therapy reduces portal pressure in patients with cirrhosis due to HBeAg-negative chronic hepatitis B and significant portal hypertension. J Hepatol. 2009 Sep;51(3):468-74. doi: 10.1016/j.jhep.2009.05.031. Epub 2009 Jul 3.
Individual participant dataSharing planned: Yes. We will share data and liver tissue with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. We may also share research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at the information.

Related trials for Alpha-1-antitrypsin Deficiency

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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.

David H. Perlmutter, M.D. principal investigator

Washington University School of Medicine

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

Questions about this trial

What is this clinical trial studying?

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 4 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 12 Oct 2021. 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 United States. 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 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.

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 12 Oct 2021). 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?

The Primary Outcome Will be to Determine the Effect of Carbamazepine on Hepatic ATZ Load. (time frame: 52 weeks). 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 NCT01379469, which also lists 48 linked publications.

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 12 Oct 2021.