Llama Antibody, Rotavirus Diarrhoea, Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01259765|
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : August 9, 2011
The investigators hypothesize that :
oral administration of VHH batch 203027 will be
- safe and tolerable for healthy Bangladeshi humans of all age groups (Part I)
- effective in reducing severity of diarrhoea in children with proven rotavirus infection (Part II). This entry only covers Part II.
|Condition or disease||Intervention/treatment||Phase|
|Male Children 6-24 Months Old With Rotaviral Diarrhoea Non-cholera Patients||Drug: VHH batch 203027 Drug: Placebo product||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Safety and Tolerability of a Novel Llama-derived Anti-rotavirus VHH Fragment in Human Volunteers (Part-I), and Its Effect on Severity and Duration of Rotavirus Diarrhoea in Children (Part II). (This Registration Only Covers Part II)|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||November 2009|
Active Comparator: VHH
The active substance is "VHH batch 203027".
Drug: VHH batch 203027
The active product is 165 mg of VHH batch 203027 and 835 mg maltodextrin with 0.5% (w/w) caramel colour in 10 mL ORS. The osmolality (concentration of the osmotically active substances in the solution such as sugar molecules, salts etc. ) of this solution will be around 60 mOsmol/kg. The mixture of the 165 mg of VHH batch 203027 and 835 mg maltodextrin (0.5% (w/w) caramel colour will be provided per sachet.
Placebo Comparator: Placebo
Drug: Placebo product
The Placebo treatment consisted of 1000 mg of maltodextrine with 5% (w/w) caramel colour in 10 mL ORS.
- Diarrhoea severity (indicated by reduced stool volume) [ Time Frame: 4-5 days ]
The primary outcome measures of this study are to evaluate the efficacy of orally administered VHH batch 203027 by its ability to reduce:
(i) diarrhoea severity (indicated by reduced stool volume) (ii) diarrhoea duration, and (iii) duration of faecal excretion of rotavirus
- Secondary aim: The secondary aim is to compare the influence of the passive immunisation with VHH on serum concentrations of anti-rotavirus antibody on day 4 and 21. [ Time Frame: 4-5 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259765
|Dhaka, Bangladesh, 1212|
|Principal Investigator:||Shafiqul A Sarker, MD, Ph. D.||International Centre for Diarrhoeal Disease Research, Bangladesh|